FDA 510(k)

Electrosurgical Generator

K-Number: K183564 · 2019-06-13

Decision Date2019-06-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator is a medical device manufactured by Fulwell, LLC. It received FDA 510(k) clearance on 2019-06-13 under approval number K183564. 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?

Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Fulwell, LLC. The 510(k) number is K183564.

When was Electrosurgical Generator approved by the FDA?

Electrosurgical Generator received FDA 510(k) clearance on 2019-06-13, under approval number K183564.

What company makes Electrosurgical Generator?

Electrosurgical Generator is manufactured by Fulwell, LLC.

What is the FDA product code for Electrosurgical Generator?

The FDA product code for Electrosurgical 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.