K252487
- 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
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
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.