Electrosurgical unit (ESU)
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00277
- 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 Office of Acquisition and Grant Services seeks procurement of one commercial electrosurgical unit (ESU) with all required accessories, with quotations due September 16, 2026. Award will be made on a Lowest Price Technically Acceptable (LPTA) basis to the responsible quoter submitting the lowest-priced quotation meeting all mandatory minimum requirements on a pass/fail basis.
Place of performance is Silver Spring, Maryland (White Oak Building 62, Room 1131, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002), with FOB Destination and delivery required within 30 calendar days of contract award.
The ESU must be newly manufactured, unused, and in full working condition at delivery. Minimum technical requirements include a touchscreen display for user interaction and parameter control; tissue impedance monitoring at a minimum rate of 434,000 times per second with real-time feedback and energy delivery adjustment; output frequency between 400 kHz and 500 kHz; and support for monopolar CUT (pure and blend), monopolar COAG (fulgurate, spray, and soft), bipolar coagulation, and vessel sealing operating modes. All required accessories must be provided and compatible with the delivered equipment: monopolar electrode and holster with switch, patient return electrode, bipolar forceps with cord and footswitch, and vessel sealer with switch. Compliance with all applicable Federal, state, and local safety standards is required.
Contract line items include the ESU and required accessories, technical documentation, installation, and manufacturer warranty and technical support for a minimum of one year. The NAICS code is 339112, Surgical and Medical Instrument Manufacturing, with a small business size standard of 1,000 employees. This procurement is not set-aside for small business. Offerors must provide technical quotations cross-referenced to minimum requirements, pricing in searchable formats, UEI and SAM.gov registration confirmation, lead time for delivery, and manufacturer and country of origin information. Questions are due by September 16, 2026 at 12:00 PM ET.
Notice 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.
Salient characteristics and any single-source need
The salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below:
Minimum technical requirements
The equipment shall meet the following minimum requirements.
Display and user interface
-
A touchscreen display for user interaction and parameter control
Tissue impedance monitoring
-
Monitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment
Output frequency
-
Output frequency within the range of 400 kHz to 500 kHz
Operating modes
The equipment shall support the following operating modes.
-
Monopolar CUT (Pure)
-
Monopolar CUT (Blend)
-
Monopolar COAG (Fulgurate)
-
Monopolar COAG (Spray)
-
Monopolar COAG (Soft)
-
Bipolar coagulation
-
Vessel sealing
Electrical and safety
-
Compliance with all applicable Federal, state, and local safety standards
Required accessories
The contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included.
-
Monopolar electrode and holster with switch, compatible with all monopolar modes.
-
Patient return electrode for monopolar operation.
-
Bipolar forceps, cord, and footswitch for bipolar coagulation.
-
Vessel sealer with switch for vessel sealing mode.
All accessories shall be compatible with the delivered equipment and ready for use upon delivery.
Files
| File | Type | Posted |
|---|---|---|
| Supplies_CSS__V2_2_260620.docx | DOCX document | |
| Attachment 1 Requirements_Document_ESU_CDRH-2026-134011_jwg.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Solicitation | |
| Electrosurgical unit (ESU) | Solicitation |
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| NX EQ surgical tissue management system | VA Strategic Acquisition Center Frederick | No set-aside |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity