510(k) K012884 ยท GCJ Laparoscope, General & Plastic Surgery
DILATING TIP OBTURATOR
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Jan 17, 2002 |
| Received | Aug 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012884
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. Terminated |
HET | None listed |
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures. Terminated |
HET | None listed |
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures. Terminated |
HET | None listed |
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures. Terminated |
HET | None listed |
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. Terminated |
GCJ | None listed |
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation nee Terminated |
GCJ | None listed |
| Oct 7, 2008 | Applied Medical Resources Corp Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cann Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.