Suture, Nonabsorbable, Synthetic, Polyamide
FDA product code GAR · Class II (moderate risk) · 21 CFR 878.5020 · General, Plastic Surgery
57510(k) clearances
0PMA approvals
13recalls
Implantimplanted device
Manufacturers
- S. Jackson, Inc. 4
- Look, Inc. 3
- United States Surgical, A Division of Tyco Healthc 3
- Aesculap, Inc. 3
- Sutures , Ltd. 3
- Artimplant AB 2
- Tas Medical, Inc. 2
- Davis & Geck, Inc. 2
- Alcon Laboratories 1
- Visitec Co. 1
- Lukens Medical Corp. 1
- Surgical Specialties Corp 1
- Surgimetrics International, Ltd. 1
- Uresil Corp. 1
- R. K. Medical L. L. C. 1
- Genzyme Surgical Product (Genzyme Biosurgery) 1
- Promedica Products, Inc. 1
- Trading Consultants and Distributors Intl., Inc. 1
- Visionary Medical Supplies, Inc. 1
- Advance Suture, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261484 | Tissue Approximation SystemGAR · Special | Tas Medical, Inc. | 06/03/2026SE |
| K220980 | Tissue Approximation System (TAS)GAR · Traditional | Tas Medical, Inc. | 07/05/2023SE |
| K212888 | Golnit Nylon Monofilament SutureGAR · Abbreviated | Antarma, LLC Dba Golnit Sutures | 03/31/2022SE |
| K212603 | Non Absorbable Surgical Nylon SutureGAR · Traditional | Shandong Haidike Medical Product Co., Ltd. | 12/22/2021SE |
| K192420 | Crownjun Nylon SutureGAR · Traditional | Kono Seisakusho Co., Ltd. | 05/29/2020SE |
| K161633 | Rexlon, RexsilGAR · Traditional | Sm Eng Co., Ltd. | 03/02/2017SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 02/17/2016SE |
| K152795 | RiverLon (Nylon) SutureGAR · Special | Riverpoint Medical | 10/28/2015SE |
| K123034 | Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional | Unilene Sac | 05/28/2013SE |
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | Nashville Surgical Instruments | 07/15/2008SE |
| K060471 | FSSB Nylon Surgical SuturesGAR · Abbreviated | Fssb Chirurgische Nadeln GmbH | 07/26/2006SE |
| K053637 | Mani Needle & Suture Pack (Nylon)GAR · Traditional | Mani, Inc. | 05/19/2006SE |
| K060528 | Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical SutureGAR · Special | Aesculap, Inc. | 03/28/2006SE |
| K052900 | Quill Nonabsorbable Nylon Barbed SutureGAR · Abbreviated | Quill Medical, Inc. | 11/28/2005SE |
| K052482 | Artelon Surgical SutureGAR · Special | Artimplant AB | 10/17/2005SE |
| K041510 | Trulon Non-Absorbable Polyamide Surgical SutureGAR · Traditional | Sutures India Private Limited | 06/02/2005SE |
| K042284 | UnimideGAR · Traditional | United Medical Industries Co. , Ltd. | 12/03/2004SE |
| K042367 | Nylon Threaded NeedleGAR · Abbreviated | Aros Surgical Instruments Corp. | 10/14/2004SE |
| K032160 | Artelon Surgical SutureGAR · Traditional | Artimplant AB | 11/17/2003SE |
| K031531 | S&T Microsurgical SutureGAR · Traditional | S & T AG | 09/23/2003SE |
| K030177 | Orlon Nonabsorable Surgical Suture UspGAR · Abbreviated | Sri Orion Pharmaceuticals & Sutures | 07/21/2003SE |
| K023028 | Demetech Nylon Nonabsorbable SutureGAR · Traditional | Demetech Corp. | 06/18/2003SE |
| K024090 | Nylon SutureGAR · Traditional | Aurolab | 02/28/2003SE |
| K020146 | SerralnylGAR · Traditional | Serral, S.A. DE C.V. | 04/15/2002SE |
| K003000 | Grams Nylon Nonabsorbable SutureGAR · Traditional | Gramsmed, LLC | 12/18/2000SE |
| K001173 | Nylon, Nonabsorbable Surgical Sutures UspGAR · Traditional | Cp Medical | 06/23/2000SN |
| K000539 | Nylon Nonabsorbable Surgical Sutures, UspGAR · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 04/27/2000SN |
| K993970 | Micrins Microsurgical SutureGAR · Traditional | Micrins Surgical, Inc. | 03/30/2000SE |
| K994176 | Sutralon Nylon SuturesGAR · Traditional | Visionary Medical Supplies, Inc. | 02/08/2000SE |
| K993998 | NylonGAR · Traditional | Trading Consultants and Distributors Intl., Inc. | 02/04/2000SE |
| K990090 | Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 03/22/1999SE |
| K981582 | Surgilon, Dermalon, & OphthalonGAR · Traditional | Davis & Geck, Inc. | 07/13/1998SE |
| K981322 | Cutalon Nylon Polyamide Surgical SutureGAR · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 07/07/1998SE |
| K960327 | Nylon Noabsorbable Surgical Sutures UspGAR · Traditional | R. K. Medical L. L. C. | 03/04/1996SN |
| K943223 | Surgidek BGAR · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K943222 | Surgidek SGAR · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K943216 | SurgidekGAR · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K931914 | Suture Non-Absorbable Synthetic PolylmideGAR · Traditional | Surgimetrics International, Ltd. | 10/05/1994SE |
| K932037 | Suture Absorbable- GutGAR · Traditional | Surgical Specialties, Inc. | 01/07/1994SE |
| K931613 | Supramid SutureGAR · Traditional | S. Jackson, Inc. | 12/17/1993SE |
| K931612 | Nylamid SutureGAR · Traditional | S. Jackson, Inc. | 12/17/1993SE |
| K930943 | Lukens Nylon Surgical SutureGAR · Traditional | Lukens Medical Corp. | 12/17/1993SE |
| K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutGAR · Traditional | Davis & Geck, Inc. | 12/17/1993SE |
| K930517 | Non-Absorbable Surgical SuturesGAR · Traditional | Alcon Laboratories | 12/17/1993SE |
| K926587 | Revised Labeling for Nylon Suture (Polyamide)GAR · Traditional | Look, Inc. | 12/17/1993SE |
| K926168 | Silk Sutures-Revised LabelingGAR · Traditional | Look, Inc. | 12/17/1993SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | Visitec Co. | 10/20/1992SE |
| K920510 | Uresil Locking General Purpose Drainage CatheterGAR · Traditional | Uresil Corp. | 09/14/1992SE |
| K913102 | Peters Cardionyl(Tm) SutureGAR · Traditional | Promedica Products, Inc. | 08/03/1992SE |
| K912429 | N80-838 Supramid Extra SutureGAR · Traditional | S. Jackson, Inc. | 10/02/1991SE |
| K903177 | Advance Suture Nonabsorbable Nylon SutureGAR · Traditional | Advance Suture, Inc. | 06/28/1991SE |
| K905286 | Ifsa Sterile Nlylon Monofil Nonabsor Surg SuturesGAR · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 02/11/1991SE |
| K904931 | Auto Suture(R) Permanent Purstring(Tm) Applier*GAR · Traditional | United States Surgical, A Division of Tyco Healthc | 01/29/1991SE |
| K905379 | Auto Suture Modified Surgitie Endo. Ligating LoopGAR · Traditional | United States Surgical, A Division of Tyco Healthc | 01/17/1991SE |
| K904052 | Supramid Extra SuturesGAR · Traditional | S. Jackson, Inc. | 10/25/1990SE |
| K903029 | Sterile Black Monofilament Nylon Non-Absor. SutureGAR · Traditional | Look, Inc. | 10/25/1990SE |
| K900531 | Nonabsorbable Nylon Surgical Suture*GAR · Traditional | United States Surgical, A Division of Tyco Healthc | 07/05/1990SN |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2920-2026 Class II | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-1294-2025 Class II | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAPTissue approximation straps (zip-ties) have broken before or during implantation so firm developed an… | TAS Medical Inc | 01/27/2025Open, Classified |
| Z-0844-2024 Class II | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41…Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma… | Covidien LP | 12/21/2023Open, Classified |
| Z-1178-2023 Class II | Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1174-2023 Class II | Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1173-2023 Class II | Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1172-2023 Class II | Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2)…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-2762-2016 Class II | Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part…Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or… | Riverpoint Medical, LLC | 08/05/2016Terminated |
| Z-2761-2016 Class II | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon…Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent… | Riverpoint Medical, LLC | 08/05/2016Terminated |
| Z-2024-2014 Class II | Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide…Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4… | Aesculap, Inc. | 06/13/2014Terminated |
| Z-1555-2014 Class II | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | Teleflex Medical | 03/11/2014Terminated |
| Z-3177-2011 | Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with…Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material. | C P Medical Inc. | 06/29/2011Terminated |
| Z-0034-2009 | 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended…mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture | Surgical Specialties Corp | 09/09/2008Terminated |