510(k) K221557 ยท HIH Hysteroscope (And Accessories)
Visera Hysterovideoscope Olympus HYF Type V
| Applicant | Olympus Medical Systems Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Sep 2, 2022 |
| Received | May 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Hysterovideoscope-For endoscopic diagnosis within the uterus
Model Number: HYF-V. Open, Classified |
HIH | None listed |
| Aug 29, 2023 | Olympus Corporation of the Americas Visera Hysterovideoscope Olympus HYF Type V Open, Classified |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.