K252487

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

510(k) number: K252487
Device name: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
Applicant: Gyrus Acmi, Inc. MA · US
Product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date: 2026-03-02
Date received: 2025-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

Also available from FDA: K252487.pdf

Official FDA record: K252487

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.