Panels › General, Plastic Surgery › Product code GAM · Class 2
Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation 878.4493
6510(k)s in 12 months (150 all time)
2recalls in 12 months (130 all time)
124recalls that name a 510(k)
Top companies in GAM
| 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 | K992088 |
| Jun 5, 2013 | Coloplast Manufacturing US, LLC Digitex Absorbable Polydiaxanone Suture, Size 2-0.
Catalog Number / Code of product: 52031, 5203101400.
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to th Terminated |
GAM | K120284 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | K053636 |
| 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 | K002190 |
| Aug 26, 2010 | Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical. Terminated |
GAM | K991191 |
| Aug 26, 2010 | Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in gener Terminated |
GAM | K905482 |
| May 18, 2010 | Ethicon, Inc. Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed.
Intended use: Soft Tissue approximation. Terminated |
GAM | K033746 K944110 +1 |
| May 12, 2009 | Ethicon, Inc. PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ.
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | None listed |
| May 12, 2009 | Ethicon, Inc. MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture;
Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | K050845 |
| May 12, 2009 | Ethicon, Inc. MONOCRYL (poliglecaprone 25 ) Suture,
Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | K960653 |
| May 12, 2009 | Ethicon, Inc. Coated VICRYL Plus Antibacterial (polyglactin 910) Suture;
Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | K032420 |
| May 12, 2009 | Ethicon, Inc. Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ 08876
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | K946271 |
| Oct 2, 2008 | Ethicon, Inc. VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP.
Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876
The product is used for Soft Tissue approximat Terminated |
GAM | K033746 K944110 +1 |
| 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 | K992088 |
| Jul 17, 2007 | Teleflex Creek Dr Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123 Terminated |
GAM | K930738 K930739 |
| Jul 17, 2007 | Teleflex Creek Dr Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114 Terminated |
GAM | K001434 K001440 +1 |
| Jul 17, 2007 | Teleflex Creek Dr Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V Terminated |
GAM | K030212 |
| Jul 17, 2007 | Teleflex Creek Dr Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, S Terminated |
GAM | K930740 |
| 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 | K992088 |
| 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 | K992088 |
| 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 | K992088 |
| 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 | K992088 |
| May 24, 2007 | C P Medical Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch Terminated |
GAM | K013274 |
| Jun 2, 2006 | Ethicon, Inc. Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lacti Terminated |
GAM | K022269 |
| May 27, 2006 | Ethicon, Inc. Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide Terminated |
GAM | K964345 K974299 |
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