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FDA 510(k)

Electrosurgical Generator

K-Number: K201221 · 2020-09-28

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2020-09-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K201221. 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 2020-09-28. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K201221.

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

Electrosurgical Generator received FDA 510(k) clearance on 2020-09-28, under 510(k) number K201221.

Who is the listed applicant for Electrosurgical Generator?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical Generator?

The FDA product code for 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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