510(k) K021019 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
| Applicant | Genzyme Corp., Fall River MA, US |
| Decision | Substantially Equivalent, Jun 18, 2002 |
| Received | Mar 29, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2014 | Teleflex Medical Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only,
Product Usage:
Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphat Terminated |
GAT | None listed |
| Mar 26, 2014 | Teleflex Medical Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only,
Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible Terminated |
GAT | None listed |
| Mar 26, 2014 | Teleflex Medical Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only,
Product Usage:
Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared Terminated |
GAT | None listed |
| Mar 26, 2014 | Teleflex Medical Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only,
Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared Terminated |
GAT | None listed |
| Mar 26, 2014 | Teleflex Medical Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only,
Product Usage:
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consis Terminated |
GAT | None listed |
| Mar 26, 2014 | Teleflex Medical Sutures, Non-absorbable, Silk, Sterile, Rx only,
Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protei Terminated |
GAT | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114 Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.