510(k) K943116 ยท HAE Rongeur, Manual
AUTO SUTURE KERRISON SPINAL RONGEUR
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Jul 27, 1994 |
| Received | Jun 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2011 | Boston Scientific Corporation Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO.
Ind Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.