510(k) K253917 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ARION ARC System
| Applicant | Plasma Surgical, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Dec 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253917
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.