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Electrosurgical unit (ESU)

ID: 75F40126Q00277 • Type: Solicitation • Match:  85%
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Description

Background
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is seeking to procure a commercial Electrosurgical Unit (ESU) to support laboratory experiments, test method development, and verification activities.

The goal of this contract is to acquire a system that can generate electromagnetic disturbance signals that emulate real-world exposure conditions.

Work Details
The contract requires the purchase, delivery, warranty, and acceptance of one (1) Electrosurgical Unit (ESU) along with all necessary accessories. The ESU must include:
- Touchscreen user interface
- Real-time tissue impedance monitoring
- Output frequency between 400 kHz and 500 kHz
- Support for monopolar, bipolar, and vessel-sealing operating modes.

Additionally, the acquisition includes:
- All accessories necessary for full operation
- User and technical documentation
- A minimum one-year manufacturer's warranty
- Delivery within 30 calendar days after contract award. The equipment must be new, unused, and fully operational upon installation.

Period of Performance
Delivery within 30 calendar days after contract award.

Place of Performance
Silver Spring MD 20993 UNITED STATES

Bidder Requirements
Bidders must provide a technical quotation that includes sufficient information such as manufacturer details, make/model number, product literature/specifications, and a cross-reference to each minimum technical requirement to demonstrate compliance. Bidders must also provide lead time for delivery along with manufacturer and country of origin for the ESU and each required accessory.

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 30 calendar days after contract award. The equipment shall be new, unused, and fully operational upon completion of required installation and shall meet all technical and functional requirements specified in the Requirements Document.

Overview

Agency
Food and Drug Administration (FDA) [HHS]
Response Deadline
Due in 4 Days
Posted
Set Aside
None
NAICS
339112 - Surgical and Medical Instrument Manufacturing
PSC
6515 - Medical And Surgical Instruments, Equipment, And Supplies
Place of Performance
Silver Spring, MD 20993 United States
Source
Open
Current SBA Size Standard
1000 Employees
Est. Level of Competition
Average
Est. Value Range
Experimental
$15,000 - $45,000 (AI estimate)
Signs of Shaping
The solicitation is open for 5 days, below average for the Food and Drug Administration. 58% of similar contracts within the Food and Drug Administration had a set-aside.
On 8/28/26 Food and Drug Administration issued Solicitation 75F40126Q00277 for Electrosurgical unit (ESU) due 9/2/26. The opportunity was issued full & open with NAICS 339112 and PSC 6515.
Primary Contact
Name
Reagan Davis   Profile
Email
reagan.davis@fda.hhs.gov
Phone
(301) 796-0910

Additional Contacts in Documents

Title Name Email Phone
None Maria Finan Profile maria.finan@fda.hhs.gov None

Documents

Posted documents for Solicitation 75F40126Q00277

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA OFFICE OF ACQ GRANT SVCS
FPDS Organization Code
7524-00223
Source Organization Code
100188033
Last Updated
Last Updated By
reagan.davis@fda.hhs.gov
Archive Date