510(k) K002190 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
| Applicant | Cp Medical, Portland OR, US |
| Decision | Substantially Equivalent for Some Indications, Aug 10, 2000 |
| Received | Jul 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2019 | CP Medical Inc Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 Open, Classified |
GAM | None listed |
| 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 |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.