FDA 510(k)

Electrosurgical Generator and Accessories

K-Number: K201224 · 2020-09-18

Decision Date2020-09-18

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator and Accessories is a medical device manufactured by Medrange. It received FDA 510(k) clearance on 2020-09-18 under approval number K201224. 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 Electrosurgical Generator and Accessories?

Electrosurgical Generator and Accessories is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Medrange. The 510(k) number is K201224.

When was Electrosurgical Generator and Accessories approved by the FDA?

Electrosurgical Generator and Accessories received FDA 510(k) clearance on 2020-09-18, under approval number K201224.

What company makes Electrosurgical Generator and Accessories?

Electrosurgical Generator and Accessories is manufactured by Medrange.

What is the FDA product code for Electrosurgical Generator and Accessories?

The FDA product code for Electrosurgical Generator and Accessories 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.