510(k) K122898 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
| Applicant | Surgical Specialties Corp. Dba Angiotech, Reading PA, US |
| Decision | Substantially Equivalent, Oct 22, 2012 |
| Received | Sep 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2022 | Ethicon, Inc. STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12]. Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.