510(k) K992088 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
| Applicant | Genzyme Surgical Product (Genzyme Biosurgery), Fall River MA, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Jun 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2014 | Teleflex Medical Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01. Terminated |
GAM | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek, TOPS ASSY P/P SLING, Catalog #84414323 Terminated |
GAM | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3 Terminated |
GAM | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Bondek, BON+ VI BR 0 HR36 Terminated |
GAM | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN, Bondek, BON+ BG Terminated |
GAM | None listed |
| Jul 17, 2007 | Teleflex Creek Dr Various Sizes of Sterile Polyglycolic Acid Synthetic Surgical Suture-NDR, POLYGLY 2-0 C-2/CST43 2N36, Catalog #833-135 Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.