510(k) K250351 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 10, 2025 |
| Received | Feb 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250351
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.