510(k) K030212 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
| Applicant | Genzyme Biosurgery, Fall River MA, US |
| Decision | Substantially Equivalent, Mar 27, 2003 |
| Received | Jan 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2014 | Teleflex Medical CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137. Terminated |
NEW | None listed |
| Apr 25, 2014 | Teleflex Medical Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 Terminated |
NEW | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.