FDA 510(k)

RF Surgical Generator

K-Number: K200931 · 2020-11-24

Decision Date2020-11-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RF Surgical Generator is a medical device manufactured by Fulwell, LLC. It received FDA 510(k) clearance on 2020-11-24 under approval number K200931. 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 RF Surgical Generator?

RF Surgical Generator is a medical device that received FDA 510(k) clearance on 2020-11-24. It is manufactured by Fulwell, LLC. The 510(k) number is K200931.

When was RF Surgical Generator approved by the FDA?

RF Surgical Generator received FDA 510(k) clearance on 2020-11-24, under approval number K200931.

What company makes RF Surgical Generator?

RF Surgical Generator is manufactured by Fulwell, LLC.

What is the FDA product code for RF Surgical Generator?

The FDA product code for RF Surgical Generator 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.