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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 a medical device manufactured by Cintron Medical Corporation. It received FDA 510(k) clearance on 2025-06-03 under approval 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. It is manufactured by Cintron Medical Corporation. The 510(k) number is K250657.

When was gi2000 Electrosurgical Generator approved by the FDA?

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

What company makes gi2000 Electrosurgical Generator?

gi2000 Electrosurgical Generator is manufactured by Cintron Medical Corporation.

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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