510(k) K930738 ยท GAL Suture, Absorbable, Natural
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
| Applicant | Deknatel, Inc., San Jose-Heredia, CR |
| Decision | Substantially Equivalent, Jul 26, 1994 |
| Received | Feb 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2014 | Teleflex Medical Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel.
Indicated for use in soft tissue approximation. Terminated |
GAR | None listed |
| May 7, 2014 | Teleflex Medical Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbabl Terminated |
GAT | None listed |
| May 7, 2014 | Teleflex Medical Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Terminated |
GAQ | None listed |
| May 7, 2014 | Teleflex Medical Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical.
Indicated for use in soft tissue approximation. Terminated |
GAM | None listed |
| May 7, 2014 | Teleflex Medical Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico.
Indicated for use in soft tissue approximation. Terminated |
GAT | None listed |
| May 7, 2014 | Teleflex Medical Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P.
Used for fixation of bone fractures, for bone reconstructions, as a g Terminated |
GAQ | None listed |
| May 7, 2014 | Teleflex Medical Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P.
Indicated for use in soft tissue approximation. Terminated |
GAP | None listed |
| Apr 24, 2014 | Teleflex Medical Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271 Terminated |
GAQ | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123 Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.