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FDA 510(k)

gi-4000 Electrosurgical Generator

K-Number: K192265 · 2020-05-21

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2020-05-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

gi-4000 Electrosurgical Generator is a medical device manufactured by United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2020-05-21 under approval number K192265. 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 gi-4000 Electrosurgical Generator?

gi-4000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by United States Endoscopy Group, Inc.. The 510(k) number is K192265.

When was gi-4000 Electrosurgical Generator approved by the FDA?

gi-4000 Electrosurgical Generator received FDA 510(k) clearance on 2020-05-21, under approval number K192265.

What company makes gi-4000 Electrosurgical Generator?

gi-4000 Electrosurgical Generator is manufactured by United States Endoscopy Group, Inc..

What is the FDA product code for gi-4000 Electrosurgical Generator?

The FDA product code for gi-4000 Electrosurgical Generator is GEI.

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Official Source

View on FDA Database →

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

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