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FDA 510(k)

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

K-Number: K213354 · 2022-03-11

Decision Date2022-03-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2022-03-11 under approval number K213354. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart?

Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Conmed Corporation. The 510(k) number is K213354.

When was Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart approved by the FDA?

Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart received FDA 510(k) clearance on 2022-03-11, under approval number K213354.

What company makes Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart?

Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart is manufactured by Conmed Corporation.

What is the FDA product code for Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart?

The FDA product code for Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.