510(k) K100006 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
| Applicant | Riverpoint Medical, Portland OR, US |
| Decision | Substantially Equivalent, May 10, 2010 |
| Received | Jan 4, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2016 | Riverpoint Medical, LLC Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers:
663BK
663BL
664BL
928BK
Product Usage:
For use in general soft t Terminated |
GAR | None listed |
| Aug 5, 2016 | Riverpoint Medical, LLC Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665
Product Usage:
For use in general soft tissue approximation and/or ligation, including use in cardio Terminated |
GAR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.