Electrosurgical unit (ESU)
Subject: Electrosurgical unit (ESU)Solicitation Number: 75F40126Q00277Notice Type: SOLICITNAICS: 339112Set-Aside: No Set aside usedNotice Published: 08-28-26Response Due: 09-02-26Agency: Department of Health and Human ServicesOffice: FOOD AND DRUG ADMINISTRATIONContact: Reagan Davis This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: (301) 796-0910Office Address: Rockville, MD 20852Place of Performance: Silver Spring, MD 20993Related Notices:
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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.