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FDA 510(k)

gi2000 Electrosurgical Generator

K-Number: K250657 · 2025-06-03

ApplicantCintron Medical Corporation
Decision Date2025-06-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

gi2000 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Cintron Medical Corporation. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K250657. 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 gi2000 Electrosurgical Generator?

gi2000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Cintron Medical Corporation. The 510(k) number is K250657.

When did gi2000 Electrosurgical Generator receive FDA 510(k) clearance?

gi2000 Electrosurgical Generator received FDA 510(k) clearance on 2025-06-03, under 510(k) number K250657.

Who is the listed applicant for gi2000 Electrosurgical Generator?

The FDA 510(k) record lists Cintron Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gi2000 Electrosurgical Generator?

The FDA product code for gi2000 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.

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