All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration. The equipment and all included accessories shall be new, unused, and in full working condition at the time of delivery.
\n\nSalient characteristics and any single-source need
\n\nThe salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below:
\n\nMinimum technical requirements
\n\nThe equipment shall meet the following minimum requirements.
\n\nDisplay and user interface
\n\nA touchscreen display for user interaction and parameter control
\n\tTissue impedance monitoring
\n\nMonitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment
\n\tOutput frequency
\n\nOutput frequency within the range of 400 kHz to 500 kHz
\n\tOperating modes
\n\nThe equipment shall support the following operating modes.
\n\nMonopolar CUT (Pure)
\n\tMonopolar CUT (Blend)
\n\tMonopolar COAG (Fulgurate)
\n\tMonopolar COAG (Spray)
\n\tMonopolar COAG (Soft)
\n\tBipolar coagulation
\n\tVessel sealing
\n\tElectrical and safety
\n\nCompliance with all applicable Federal, state, and local safety standards
\n\tRequired accessories
\n\nThe contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included.
\n\nMonopolar electrode and holster with switch, compatible with all monopolar modes.
\n\tPatient return electrode for monopolar operation.
\n\tBipolar forceps, cord, and footswitch for bipolar coagulation.
\n\tVessel sealer with switch for vessel sealing mode.
\n\tAll accessories shall be compatible with the delivered equipment and ready for use upon delivery.
","text":"All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration. The equipment and all included accessories shall be new, unused, and in full working condition at the time of delivery.\n\nSalient characteristics and any single-source need\n\nThe salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below:\n\nMinimum technical requirements\n\nThe equipment shall meet the following minimum requirements.\n\nDisplay and user interface\n\n•\nA touchscreen display for user interaction and parameter control\n\nTissue impedance monitoring\n\n•\nMonitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment\n\nOutput frequency\n\n•\nOutput frequency within the range of 400 kHz to 500 kHz\n\nOperating modes\n\nThe equipment shall support the following operating modes.\n\n•\nMonopolar CUT (Pure)\n\n•\nMonopolar CUT (Blend)\n\n•\nMonopolar COAG (Fulgurate)\n\n•\nMonopolar COAG (Spray)\n\n•\nMonopolar COAG (Soft)\n\n•\nBipolar coagulation\n\n•\nVessel sealing\n\nElectrical and safety\n\n•\nCompliance with all applicable Federal, state, and local safety standards\n\nRequired accessories\n\nThe contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included.\n\n•\nMonopolar electrode and holster with switch, compatible with all monopolar modes.\n\n•\nPatient return electrode for monopolar operation.\n\n•\nBipolar forceps, cord, and footswitch for bipolar coagulation.\n\n•\nVessel sealer with switch for vessel sealing mode.\n\nAll accessories shall be compatible with the delivered equipment and ready for use upon delivery.","origin":"detail"},"notice_type":{"code":"k","label":"Combined Synopsis/Solicitation"},"schema_version":1,"solicitation_number":"75F40126Q00277","place_of_performance":{"zip":"20993","city":{"code":"72450","name":"Silver Spring"},"state":{"code":"MD","name":"Maryland"},"country":{"code":"USA","name":"UNITED STATES"}},"product_service_code":"6515"}],"due_at":"2026-09-16T17:00:00Z","due_date":"2026-09-16","closes_at":"2026-09-16T17:00:00Z","awardable":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","state":"MD","country":"USA","winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T07:31:38.954589Z","principal_notice_id":"93cb831e158f4ae090cfb682c880d645","description":{"text":"All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration. The equipment and all included accessories shall be new, unused, and in full working condition at the time of delivery.\n\nSalient characteristics and any single-source need\n\nThe salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below:\n\nMinimum technical requirements\n\nThe equipment shall meet the following minimum requirements.\n\nDisplay and user interface\n\n•\nA touchscreen display for user interaction and parameter control\n\nTissue impedance monitoring\n\n•\nMonitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment\n\nOutput frequency\n\n•\nOutput frequency within the range of 400 kHz to 500 kHz\n\nOperating modes\n\nThe equipment shall support the following operating modes.\n\n•\nMonopolar CUT (Pure)\n\n•\nMonopolar CUT (Blend)\n\n•\nMonopolar COAG (Fulgurate)\n\n•\nMonopolar COAG (Spray)\n\n•\nMonopolar COAG (Soft)\n\n•\nBipolar coagulation\n\n•\nVessel sealing\n\nElectrical and safety\n\n•\nCompliance with all applicable Federal, state, and local safety standards\n\nRequired accessories\n\nThe contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included.\n\n•\nMonopolar electrode and holster with switch, compatible with all monopolar modes.\n\n•\nPatient return electrode for monopolar operation.\n\n•\nBipolar forceps, cord, and footswitch for bipolar coagulation.\n\n•\nVessel sealer with switch for vessel sealing mode.\n\nAll accessories shall be compatible with the delivered equipment and ready for use upon delivery.","html":"All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration. The equipment and all included accessories shall be new, unused, and in full working condition at the time of delivery.
\n\nSalient characteristics and any single-source need
\n\nThe salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below:
\n\nMinimum technical requirements
\n\nThe equipment shall meet the following minimum requirements.
\n\nDisplay and user interface
\n\nA touchscreen display for user interaction and parameter control
\n\tTissue impedance monitoring
\n\nMonitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment
\n\tOutput frequency
\n\nOutput frequency within the range of 400 kHz to 500 kHz
\n\tOperating modes
\n\nThe equipment shall support the following operating modes.
\n\nMonopolar CUT (Pure)
\n\tMonopolar CUT (Blend)
\n\tMonopolar COAG (Fulgurate)
\n\tMonopolar COAG (Spray)
\n\tMonopolar COAG (Soft)
\n\tBipolar coagulation
\n\tVessel sealing
\n\tElectrical and safety
\n\nCompliance with all applicable Federal, state, and local safety standards
\n\tRequired accessories
\n\nThe contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included.
\n\nMonopolar electrode and holster with switch, compatible with all monopolar modes.
\n\tPatient return electrode for monopolar operation.
\n\tBipolar forceps, cord, and footswitch for bipolar coagulation.
\n\tVessel sealer with switch for vessel sealing mode.
\n\tAll accessories shall be compatible with the delivered equipment and ready for use upon delivery.
","origin":"detail"},"contacts":[{"name":"Reagan Davis","role":"primary","email":"reagan.davis@fda.hhs.gov","phone":"3017960910"}],"place_of_performance":{"zip":"20993","city":{"code":"72450","name":"Silver Spring"},"state":{"code":"MD","name":"Maryland"},"country":{"code":"USA","name":"UNITED STATES"}},"office_address":{"zip":"20852","city":"Rockville","state":"MD","country":"USA"},"naics_codes":["339112"],"award":null,"attachments":[{"resource_id":"2b7dd373efd9482b9f1d60c82f38cb85","name":"Attachment 1 Requirements_Document_ESU_CDRH-2026-134011_jwg.docx","kind":"file","mime_type":".docx","size_bytes":38236,"posted_at":"2026-09-10T16:58:20.124Z","export_controlled":false,"sha256":null,"url":"https://sam.gov/api/prod/opps/v3/opportunities/resources/files/2b7dd373efd9482b9f1d60c82f38cb85/download","mirrored":false}],"awards":[],"related":[{"key":"75F40126Q00381","latest_notice_id":"098ad8ecd3e148fba56d1031d023ffe3","title":"Endoscopy Systems","solicitation_number":"75F40126Q00381","notice_type":"k","first_type":"k","first_posted":"2026-09-10","last_posted":"2026-09-14","notices":2,"due_at":"2026-09-16T19:00:00Z","due_date":"2026-09-16","closes_at":"2026-09-16T19:00:00Z","awardable":true,"open":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","naics":"423490","psc":"6640","set_aside":null,"state":"MD","country":"USA","winner":null,"winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T07:31:38.954589Z"},{"key":"75F40126Q00371","latest_notice_id":"7d8b4bca78f24f24b2734f3e2c9c8ca5","title":"QELS Dynamic Light Scattering Detector","solicitation_number":"75F40126Q00371","notice_type":"k","first_type":"k","first_posted":"2026-09-10","last_posted":"2026-09-10","notices":1,"due_at":"2026-09-16T19:00:00Z","due_date":"2026-09-16","closes_at":"2026-09-16T19:00:00Z","awardable":true,"open":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","naics":"334516","psc":"6640","set_aside":null,"state":"MO","country":"USA","winner":null,"winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T07:31:38.954589Z"},{"key":"RFQCDR2026135968","latest_notice_id":"0a2d3e56451c4afa948835a62000bb09","title":"Human Hindbrain Organoid Functional Assay Services.","solicitation_number":"RFQ_CDR-2026-135968","notice_type":"k","first_type":"k","first_posted":"2026-09-11","last_posted":"2026-09-11","notices":1,"due_at":"2026-09-17T14:30:00Z","due_date":"2026-09-17","closes_at":"2026-09-17T14:30:00Z","awardable":true,"open":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","naics":"541714","psc":"B504","set_aside":null,"state":null,"country":null,"winner":null,"winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T07:31:38.954589Z"},{"key":"75F40126Q00386","latest_notice_id":"27e99454af4c4254b10a9b32de928143","title":"Walk-In Laboratory Cooler","solicitation_number":"75F40126Q00386","notice_type":"o","first_type":"o","first_posted":"2026-09-10","last_posted":"2026-09-15","notices":4,"due_at":"2026-09-18T18:30:00Z","due_date":"2026-09-18","closes_at":"2026-09-18T18:30:00Z","awardable":true,"open":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","naics":"333415","psc":"4110","set_aside":null,"state":null,"country":null,"winner":null,"winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T07:50:43.959643Z"},{"key":"75F40126Q00407","latest_notice_id":"dc8b1da2c3b8402b93fcd096bc1f5681","title":"Rapid Nicotine Pouch Data Analysis Services","solicitation_number":"75F40126Q00407","notice_type":"k","first_type":"k","first_posted":"2026-09-14","last_posted":"2026-09-14","notices":1,"due_at":"2026-09-18T19:00:00Z","due_date":"2026-09-18","closes_at":"2026-09-18T19:00:00Z","awardable":true,"open":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","naics":"541618","psc":"R405","set_aside":null,"state":"MD","country":"USA","winner":null,"winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T07:31:38.954589Z"}]}