FDA 510(k)

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

Numéro K : K213135 · 2022-03-02

Date de décision2022-03-02

Code produitFAS

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is the device name listed in this FDA 510(k) record. The listed applicant is Chirurgie Innovation. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213135. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Chirurgie Innovation. The 510(k) number is K213135.

When did Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge receive FDA 510(k) clearance?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213135.

Who is the listed applicant for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

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

What is the FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

The FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is FAS.

Essais cliniques associés

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Autres dossiers indiquant Chirurgie Innovation en tant que demandeur

K163090Plasma Edge System

Dispositifs connexes (Code : FAS)

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Source officielle

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