510(k) K102839 ยท GCJ Laparoscope, General & Plastic Surgery
SPIDER STANDARD AND ADVANCED
| Applicant | Transenterix, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Mar 15, 2011 |
| Received | Sep 29, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2011 | Transenterix, Inc SPIDER ADVANCED 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-s Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.