Suture, Nonabsorbable, Silk
FDA product code GAP · Class II (moderate risk) · 21 CFR 878.5030 · General, Plastic Surgery
41510(k) clearances
0PMA approvals
28recalls
Implantimplanted device
Manufacturers
- United States Surgical, A Division of Tyco Healthc 5
- M/s. Meril Endo Surgery Private Limited. 2
- Safepath Medical, Inc. 2
- Surgical Specialties Corp 2
- Sutures , Ltd. 1
- Gramsmed, LLC 1
- Cp Medical 1
- Covidien LLC 1
- Visionary Medical Supplies, Inc. 1
- Trading Consultants and Distributors Intl., Inc. 1
- Davis & Geck, Inc. 1
- Aesculap, Inc. 1
- R. K. Medical L. L. C. 1
- Alcon Laboratories 1
- Deknatel, Inc. 1
- Visitec Co. 1
- Surgimetrics International, Ltd. 1
- Advance Suture, Inc. 1
- Internacional Farmaceutica, S.A. DE C.V. 1
- Draeger Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | Covidien | 12/03/2024SE |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…GAP · Traditional | Safepath Medical, Inc. | 10/18/2024SE |
| K232355 | Non absorbable Surgical Silk SutureGAP · Traditional | Shandong Haidike Medical Product Co., Ltd. | 01/16/2024SE |
| K221767 | Surgical Sutures with or without NeedleGAP · Traditional | Huaian Seamen Medical Technology Co., Ltd. | 07/31/2023SE |
| K180701 | SafePath Suturing SystemGAP · Traditional | Safepath Medical, Inc. | 06/25/2018SE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special | M/s. Meril Endo Surgery Private Limited. | 10/20/2017SE |
| K162396 | SILK Surgical SutureGAP · Traditional | Teleflexmedical, Inc. | 11/23/2016SE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional | M/s. Meril Endo Surgery Private Limited. | 05/31/2016SE |
| K080684 | Wg-Surgical Sutures with NeedleGAP · Traditional | Foosin Medical Supplies, Inc. | 06/09/2008SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | Arrow Intl., Inc. | 07/17/2007SE |
| K053638 | Mani Needle & Suture Pack (Silk)GAP · Traditional | Mani, Inc. | 05/19/2006SE |
| K041514 | Truesilk Non-Absorbable Silk Surgical SutureGAP · Traditional | Sutures India Private Limited | 06/03/2005SE |
| K042282 | UnisilkGAP · Traditional | United Medical Industries Co. , Ltd. | 12/01/2004SE |
| K024091 | Silk SuturesGAP · Traditional | Aurolab | 02/28/2003SE |
| K023029 | Demetech Silk Nonabsorbable SutureGAP · Traditional | Demetech Corp. | 11/25/2002SE |
| K020901 | SerralsilkGAP · Traditional | Serral, S.A. DE C.V. | 04/26/2002SE |
| K012124 | Mersilk Black Silk Braided Non-Absorbable Suture, UspGAP · Traditional | Johnson & Johnson Medical (China) , Ltd. | 09/19/2001SE |
| K003001 | Grams Silk Nonabsorbable SutureGAP · Traditional | Gramsmed, LLC | 12/15/2000SE |
| K001184 | Silk, Nonabsorbable, Surgical Sutures, UspGAP · Traditional | Cp Medical | 06/23/2000SN |
| K000541 | Silk Nonabsorbable Surgical Sutures, UspGAP · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 04/28/2000SE |
| K994177 | Sutrasilk Silk SutureGAP · Traditional | Visionary Medical Supplies, Inc. | 02/08/2000SE |
| K993999 | SilkGAP · Traditional | Trading Consultants and Distributors Intl., Inc. | 02/04/2000SE |
| K982853 | Silk SutureGAP · Traditional | Davis & Geck, Inc. | 04/30/1999SN |
| K990089 | Silkam Nonabsorbable Silk Surgical SutureGAP · Traditional | Aesculap, Inc. | 03/15/1999SE |
| K981128 | Sofsilk SutureGAP · Traditional | United States Surgical, A Division of Tyco Healthc | 05/11/1998SE |
| K980124 | Sofsilk SutureGAP · Traditional | United States Surgical, A Division of Tyco Healthc | 03/27/1998SE |
| K964581 | SofsilkGAP · Traditional | United States Surgical, A Division of Tyco Healthc | 01/16/1997SN |
| K960328 | Silk Nonabsorbable Surgical Sutures UspGAP · Traditional | R. K. Medical L. L. C. | 03/04/1996SN |
| K943627 | SurgisilkGAP · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K930739 | Sutures Polyprop., Polyetheline, Nylon & SilkGAP · Traditional | Deknatel, Inc. | 07/26/1994SE |
| K942234 | Visitec Precise-PointGAP · Traditional | Visitec Co. | 07/12/1994SE |
| K931913 | Suture Non-Absorbable SilkGAP · Traditional | Surgimetrics International, Ltd. | 03/03/1994SE |
| K930826 | Suture Nonabsorbable - SilkGAP · Traditional | Surgical Specialties, Inc. | 01/07/1994SE |
| K930825 | Suture Nonabsorbable-Nylon,Silk,Polyester,StainlesGAP · Traditional | Surgical Specialties, Inc. | 01/07/1994SE |
| K905454 | Advance Suture Nonabsorbable Silk SutureGAP · Traditional | Advance Suture, Inc. | 06/28/1991SE |
| K905287 | Ifsa Sterile Silk Braided Nonabsor Surg SuturesGAP · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 02/11/1991SE |
| K904891 | Nonabsorbable Silk Surgical Suture (Second Source)GAP · Traditional | United States Surgical, A Division of Tyco Healthc | 11/14/1990SN |
| K904478 | Nonabsorbable Silk Surgical SutureGAP · Traditional | United States Surgical, A Division of Tyco Healthc | 11/14/1990SN |
| K761199 | Airway Pressure MonitorGAP · Traditional | Draeger Medical, Inc. | 02/28/1977SE |
| K760650 | Retractor, Gerbode SternalGAP · Traditional | Dilling Co. | 09/21/1976SE |
| K760158 | Needles and Sutures, Silk & NylonGAP · Traditional | Alcon Laboratories | 08/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1697-2024 Class II | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile…One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles.… | Covidien, LP | 01/25/2024Open, Classified |
| Z-0845-2024 Class II | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0…Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma… | Covidien LP | 12/21/2023Open, Classified |
| Z-1176-2023 Class II | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-2486-2020 Class II | PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768…Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years | Ethicon, Inc. | 06/10/2020Open, Classified |
| Z-0747-2019 Class II | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code…The sutures inside the packaging are not the same size or type as indicated on the label. | Ethicon, Inc. | 12/18/2018Terminated |
| Z-0492-2015 Class II | Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC-…Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected… | Ethicon, Inc. | 10/17/2014Terminated |
| Z-1561-2014 Class II | Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | Teleflex Medical | 03/11/2014Terminated |
| Z-2830-2011 | Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, non-absorbable polyester sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2829-2011 | Syneture Ti-Cron 2 BLUE 5X18" HGS-22 non-absorbable polyester sutures Material…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2828-2011 | Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2827-2011 | Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2826-2011 | Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH non-absorbable polyester sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2825-2011 | Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2824-2011 | Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2823-2011 | Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2822-2011 | Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2821-2011 | Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2820-2011 | Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2819-2011 | Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE non-absorbable braided nylon sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2818-2011 | Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2817-2011 | Syneture Sofsilk 2/0 30" BLACK V-20 DT non-absorbable braided nylon sutures GS66M…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2816-2011 | Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon sutures GS63M…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2815-2011 | Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH non-absorbable silk sutures GS62M Sofsilk…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2814-2011 | Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS46M Sofsilk is…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2813-2011 | Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M Sofsilk is…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2812-2011 | Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures GS43M…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2811-2011 | Syneture Sofsilk 3/0 18" BLACK CV-25 DT non-absorbable silk sutures GS33M Sofsilk is…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |
| Z-2810-2011 | Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon sutures CS10M Sofsilk…Potential for the sterile barrier to be breached compromising the sterility of the product | Covidien LP | 06/03/2011Terminated |