FDA 510(k)

Electrosurgical accessory

K-Number: K210394 · 2021-05-19

Decision Date2021-05-19

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Electrosurgical accessory is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K210394. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrosurgical accessory?

Electrosurgical accessory is a medical device that received FDA 510(k) clearance on 2021-05-19. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K210394.

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

Electrosurgical accessory received FDA 510(k) clearance on 2021-05-19, under 510(k) number K210394.

Who is the listed applicant for Electrosurgical accessory?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical accessory?

The FDA product code for Electrosurgical accessory is FAS.

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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.