510(k) K252043 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Sep 23, 2025 |
| Received | Jun 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252043
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.