510(k) K952535 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
ACUFEX ENDOBUTTON TAPE
| Applicant | Acufex Microsurgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent for Some Indications, Feb 8, 1996 |
| Received | Jun 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2017 | Smith & Nephew, Inc. Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 Terminated |
MAI | None listed |
| Jul 19, 2016 | Smith & Nephew, Inc. Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction. Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.