510(k) K252487 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
| Applicant | Gyrus Acmi, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Mar 2, 2026 |
| Received | Aug 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252487
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.