510(k) K013274 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
| Applicant | Cp Medical, Portland OR, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Oct 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2011 | C P Medical Inc. Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. Terminated |
NEW | None listed |
| Sep 27, 2010 | C P Medical Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 E Terminated |
NEW | None listed |
| May 24, 2007 | C P Medical Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.