510(k) K090902 ยท GCJ Laparoscope, General & Plastic Surgery
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003
| Applicant | Transenterix, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Jul 22, 2009 |
| Received | Apr 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2011 | Transenterix, Inc SPIDER Surgical Platform
The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-steriliz Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.