510(k) K190744 ยท HET Laparoscope, Gynecologic (And Accessories)
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | Mar 22, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190744
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Olympus Corporation of the Americas Olympus ENDOEYE HD II Rigid Videoscope
Catalog Numbers: WA50040A, WA50042A
-used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and Open, Classified |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.