# K213354: Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Mar 11, 2022 after 150 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911904 (1991). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172671: HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal, Conmed Corporation (2017) Summary page 5.
- K170170: Valleylab FT10 Electrosurgical Platform, Covidien, LLC (2017) Summary page 5.
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, Covidien (2017) Summary page 5.

## Indications for use
Unify Multifunction Energy Platform and Unify Cart The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired. This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. This generator, when used with compatible vessel sealing devices, is indicated for the ligation and division of tissue bundles, lymphatics, and vessels in open and laparoscopic procedures. Reference instructions for use (IFU) for applicable vessel sealing devices. The vessel sealing function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. CleanSeal Vessel Sealers CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 7 mm vessels (arteries and veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic and vascular. These procedures include, but are not limited to, hysterectomies, oophorectomies, colectomies, Nissen fundoplication, and adhesiolysis. The CleanSeal Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CleanSeal Vessel Sealer for these procedures. Unify Bipolar Resection Cables The CONMED UNIFY Bipolar Resection Cables are used to connect compatible accessories to the CONMED UNIFY ESU. UNIFY Bipolar Resection Cables are used in conjunction with the Bipolar Resection capabilities of the UNIFY ESU for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. The CONMED UNIFY Bipolar Resection Cables are intended for use with only compatible resectoscopes (refer to Compatibility for details). Maximum rated voltage 750 V. Unify Wireless FootSwitch The Wireless Footswitch Kit is intended for use with the CONMED UNIFY™ Advanced Energy Generator for the operation of foot-controlled RF devices.

Source page: https://510kreport.com/device/K213354
Methodology: https://510kreport.com/methodology