510(k) K111425 ยท HET Laparoscope, Gynecologic (And Accessories)
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
| Applicant | Olympus Medical Systems Corp., Center Valley PA, US |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | May 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Olympus Corporation of the Americas OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter)
Model: LTF-S190-10
Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical uni Open, Classified |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.