510(k) K234147 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference
| Applicant | Microline Surgical, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Apr 23, 2024 |
| Received | Dec 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234147
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.