FDA 510(k)

MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Numéro K : K210942 · 2021-05-14

Date de décision2021-05-14

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

MicroFrance Monopolar and Bipolar Electrosurgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Integra Microfrance. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K210942. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MicroFrance Monopolar and Bipolar Electrosurgical Instruments?

MicroFrance Monopolar and Bipolar Electrosurgical Instruments is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Integra Microfrance. The 510(k) number is K210942.

When did MicroFrance Monopolar and Bipolar Electrosurgical Instruments receive FDA 510(k) clearance?

MicroFrance Monopolar and Bipolar Electrosurgical Instruments received FDA 510(k) clearance on 2021-05-14, under 510(k) number K210942.

Who is the listed applicant for MicroFrance Monopolar and Bipolar Electrosurgical Instruments?

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

What is the FDA product code for MicroFrance Monopolar and Bipolar Electrosurgical Instruments?

The FDA product code for MicroFrance Monopolar and Bipolar Electrosurgical Instruments is GEI.

Essais cliniques associés

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Source officielle

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