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FDA 510(k)

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

K-Number: K252487 · 2026-03-02

ApplicantGyrus Acmi, Inc.
Decision Date2026-03-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2026-03-02 under approval number K252487. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K252487.

When was POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) approved by the FDA?

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

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

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) is manufactured by Gyrus Acmi, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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