SAM #SSN-CDRH-2026-134011

FDA seeks commercial Electrosurgical Unit with accessories and warranty

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is seeking to procure one commercial Electrosurgical Unit (ESU) with accessories and warranty. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Products/Services Requested: - One (1) commercial Electrosurgical Unit (ESU) - Touchscreen user interface - Real-time tissue impedance monitoring - Output frequency between 400 kHz and 500 kHz - Supports monopolar, bipolar, and vessel-sealing operating modes - Includes all required accessories for full operation - User and technical documentation - Minimum one-year manufacturer's warranty (covers parts, labor, and service) - Equipment must be new, unused, and fully operational upon delivery - Delivery Requirements: - Delivery within 60 calendar days after contract award - Unique/Notable Requirements: - Compliance with Buy American statutes - Seeking capable small businesses - No specific OEMs or brands mentioned; open to any manufacturer meeting technical specifications

Description

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. 

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