Electrosurgical unit (ESU)

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.

• NAICS339112
• PSC6515

• Supplies_CSS__V2_2_260620.docx

  .docx68 KBNot yet available
• Attachment 1 Requirements_Document_ESU_CDRH-2026-134011_jwg.docx

  .docx37 KBNot yet available

• Reagan Davis
  reagan.davis@fda.hhs.gov3017960910