510(k) K930511 ยท GCJ Laparoscope, General & Plastic Surgery
STEALTH SURGICAL IRRIGATOR ASPIRATOR
| Applicant | W. J. Medical Instruments, Inc., Newbury Park CA, US |
| Decision | Substantially Equivalent, Jun 25, 1993 |
| Received | Feb 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2007 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575. Terminated |
GEI | None listed |
| Aug 14, 2007 | Zinnanti Surgical Design LLC Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.