510(k) K201832 ยท HET Laparoscope, Gynecologic (And Accessories)
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 17, 2021 |
| Received | Jul 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Olympus Corporation of the Americas OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter)
Model: LTF-S190-5
Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical un Open, Classified |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.