510(k) K213207 ยท HIH Hysteroscope (And Accessories)
Sheath, Stopcock Accessory
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Sep 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213207
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.