510(k) K891451 ยท HIH Hysteroscope (And Accessories)
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Oct 2, 1989 |
| Received | Mar 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Hysteroscope-For endoscopic diagnosis within the uterus
Model Number: HYF-1T. Open, Classified |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.