FDA 510(k)

POWERSEAL Curved Jaw Sealer and Divider, Double Action

Numéro K : K212643 · 2021-09-27

DemandeurOlympus Surgical Technologies America

Date de décision2021-09-27

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

POWERSEAL Curved Jaw Sealer and Divider, Double Action is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K212643. 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 POWERSEAL Curved Jaw Sealer and Divider, Double Action?

POWERSEAL Curved Jaw Sealer and Divider, Double Action is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K212643.

When did POWERSEAL Curved Jaw Sealer and Divider, Double Action receive FDA 510(k) clearance?

POWERSEAL Curved Jaw Sealer and Divider, Double Action received FDA 510(k) clearance on 2021-09-27, under 510(k) number K212643.

Who is the listed applicant for POWERSEAL Curved Jaw Sealer and Divider, Double Action?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERSEAL Curved Jaw Sealer and Divider, Double Action?

The FDA product code for POWERSEAL Curved Jaw Sealer and Divider, Double Action is GEI.

Essais cliniques associés

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Source officielle

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