Electrosurgical Unit
Closed Pre-Solicitation Posted
- Solicitation number
- SSN-CDRH-2026-134011
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339112 Surgical and Medical Instrument Manufacturing
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA's Center for Devices and Radiological Health (CDRH) intends to solicit the purchase, delivery, warranty, and acceptance of one commercial Electrosurgical Unit (ESU) and all required accessories, with a Sources Sought notice response deadline of July 20, 2026. No set-aside is anticipated.
The ESU must generate electromagnetic disturbance signals to emulate real-world exposure conditions in support of laboratory experiments, test method development, and verification activities. The system shall include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, and support monopolar, bipolar, and vessel-sealing operating modes. The equipment must be new, unused, and fully operational upon delivery, with all accessories, user and technical documentation, and a minimum one-year manufacturer's warranty included. Delivery is required within 60 calendar days after contract award.
Place of performance is White Oak Building 62, Room 1135, Silver Spring, Maryland. NAICS 339112 (Surgical and Medical Instrument Manufacturing; 1,000-employee size standard) and PSC 6515 apply. The Sources Sought notice (RFO Part 10 market research) requests responses in native Microsoft Excel format for the Vendor Response Form and PDF format for capability statements not exceeding 5 pages. Responses must address small business capability, technical capability including manufacturer details, compliance matrix, accessory confirmation, specifications and warranty coverage, and domestic manufacture and availability.
Notice text
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires the purchase, delivery, warranty, and acceptance of one (1) commercial Electrosurgical Unit (ESU) and all required accessories. The ESU will be used to generate electromagnetic disturbance signals that emulate real-world exposure conditions in support of laboratory experiments, test method development, and verification activities. The system shall include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, and support monopolar, bipolar, and vessel-sealing operating modes. The acquisition includes all accessories necessary for full operation, user and technical documentation, a minimum one-year manufacturer's warranty, and delivery within 60 calendar days after contract award. The equipment shall be new, unused, fully operational upon delivery, and meet all technical and functional requirements specified in the Requirements Document. The anticipated quantity is one (1) complete system, including all accessories, documentation, and warranty required by the Requirements Document.
Files
| File | Type | Posted |
|---|---|---|
| Sources_Sought.docx | DOCX document |
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