510(k) K984355 ยท GCJ Laparoscope, General & Plastic Surgery
POINT SETTER
| Applicant | Mitaka USA, Inc., Park City UT, US |
| Decision | Substantially Equivalent, Apr 1, 1999 |
| Received | Dec 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2012 | Mitaka USA, Inc. Mitaka Point Setter, holding system for surgical instruments.
Holding surgical instruments during operating procedures. Terminated |
GWG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.