FDA 510(k)

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

Numéro K : K252487 · 2026-03-02

Date de décision2026-03-02

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252487. 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 Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K252487.

When did POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) receive FDA 510(k) clearance?

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252487.

Who is the listed applicant for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

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

What is the FDA product code for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

The FDA product code for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is GEI.

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Source officielle

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