510(k) K060096 ยท GCJ Laparoscope, General & Plastic Surgery
MODULAR TROCAR SYSTEM
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Jan 24, 2006 |
| Received | Jan 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2026 | Applied Medical Resources Corp Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm
REF: CTB23 Open, Classified |
GCJ | None listed |
| Jun 14, 2017 | Applied Medical Resources Corp Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and
Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars. Terminated |
GCJ | None listed |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | None listed |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | None listed |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | None listed |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | None listed |
| Sep 18, 2009 | Applied Medical Resources Corp Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile.
Disposable single-use devices indicated for use in general, abdominal, gynecological and Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.