510(k) K193039 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Single Use Balloon Dilator V (with knife)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Dec 17, 2019 |
| Received | Oct 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193039
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.