510(k) K100461 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
| Applicant | Riverpoint Medical, Portland OR, US |
| Decision | Substantially Equivalent, Jul 8, 2010 |
| Received | Feb 18, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2013 | Riverpoint Medical, LLC Polyglycolic-Lactic Acid Absorbable Surgical Suture
Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***"
PGLA surgical suture is indicated for use in Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.