510(k) K963999 ยท OCW Endoscopic Tissue Approximation Device
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Nov 27, 1996 |
| Received | Oct 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2010 | Covidien LP Auto Suture ProTack Fixation 5 mm
Product Catalogue # 174006.
Has application in endoscopic surgery procedures. Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.