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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 the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) 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. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K192265.

When did gi-4000 Electrosurgical Generator receive FDA 510(k) clearance?

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

Who is the listed applicant for gi-4000 Electrosurgical Generator?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing United States Endoscopy Group, Inc. as applicant

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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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