510(k) K002639 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
BIOKNOTLESS ANCHOR
| Applicant | Mitek Products, Norwood MA, US |
| Decision | Substantially Equivalent, May 11, 2001 |
| Received | Aug 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2006 | Depuy Mitek, a Johnson & Johnson Co. Depuy Mitek Bioknotless Anchor with Ethibond Suture
Ref No. 212728 Terminated |
MAI | None listed |
| Mar 15, 2006 | Depuy Mitek, a Johnson & Johnson Co. Depuy Mitek Bioknotless Anchor with Panacryl Suture
Ref No. 212729 Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.