510(k) K101937 ยท GCJ Laparoscope, General & Plastic Surgery
HYBRID TROCAR SYSTEM
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | Jul 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2024 | Aesculap Inc DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. Open, Classified |
GCJ | None listed |
| Mar 1, 2024 | Aesculap Inc DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures. Open, Classified |
GCJ | None listed |
| Mar 1, 2024 | Aesculap Inc DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures. Open, Classified |
GCJ | None listed |
| Mar 1, 2024 | Aesculap Inc DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures. Open, Classified |
GCJ | None listed |
| Mar 1, 2024 | Aesculap Inc DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures. Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.