510(k) K091697 ยท GCJ Laparoscope, General & Plastic Surgery
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
| Applicant | Transenterix, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Sep 28, 2009 |
| Received | Jun 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091697
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2012 | Transenterix, Inc SPIDER Surgical Instrument: Flexible Clip Applier
The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutt Terminated |
GCJ | None listed |
| Sep 22, 2010 | Transenterix, INC Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.