510(k) K923982 ยท GCJ Laparoscope, General & Plastic Surgery
OLYMPUS OES LAPAROSCOPY SYSTEM
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Mar 15, 1993 |
| Received | Aug 7, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2010 | Olympus America Inc. Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L
Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscop Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.