Suture, Nonabsorbable, Synthetic, Polypropylene
FDA product code GAW · Class II (moderate risk) · 21 CFR 878.5010 · General, Plastic Surgery
85510(k) clearances
1PMA approvals
28recalls
Implantimplanted device
Manufacturers
- Axya Medical 5
- Surgical Specialties Corp 5
- Sutura, Inc. 4
- ETHICON, Inc. 4
- United States Surgical, A Division of Tyco Healthc 3
- Aesculap, Inc. 3
- Nobles Medical Technologies Ii, Inc. 3
- Look, Inc. 2
- Abbott Vascular 2
- Angiotech 2
- Silhouette Lift, Inc. 2
- Davis & Geck, Inc. 2
- S. Jackson, Inc. 2
- Kmi Kolster Methods, Inc. 2
- Surgical Specialties Corp. Dba Angiotech 2
- Deknatel, Inc. 2
- Surgimetrics International, Ltd. 1
- Sutures , Ltd. 1
- Cypris Medical 1
- Advance Suture, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | ETHICON, Inc. | 03/27/2026SE |
| K233355 | Cypris eXact Suturing SystemGAW · Traditional | Cypris Medical | 01/12/2024SE |
| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
| K221280 | VessealGAW · Traditional | Lydus Medical , Ltd. | 12/09/2022SE |
| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
| K173644 | Gazelle Polypropylene Suture and Delivery DeviceGAW · Abbreviated | Dura Tap, LLC | 02/15/2018SE |
| K171039 | Assut Filbloc Permanent SuturesGAW · Abbreviated | Assut Europe S.P.A. | 08/29/2017SE |
| K171005 | Silhouette FeatherliftGAW · Special | Silhouette Lift, Inc. | 05/03/2017SE |
| K162617 | NobleStitch ELGAW · Abbreviated | Nobles Medical Technologies Ii, Inc. | 04/06/2017SESU |
| K160529 | Pledgeted COR-SUTURE QUICK LOADGAW · Abbreviated | Lsi Soultions | 09/15/2016SE |
| K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelGAW · Traditional | Resorba Medical GmbH | 10/29/2015SE |
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignGAW · Special | Angiotech | 09/10/2015SE |
| K141206 | Edwards Lifesciences Thruport Knotting SystemGAW · Traditional | Edwards Lifesciences, LLC | 01/16/2015SE |
| K142639 | StitchKitGAW · Traditional | Origami Surgical, LLC | 12/16/2014SE |
| K133890 | Aesculap Optilene Nonabsorbable SutureGAW · Traditional | Aesculap, Inc. | 07/15/2014SE |
| K133356 | Prolene Polypropylene Nonabsorbable SutureGAW · Special | ETHICON, Inc. | 12/06/2013SE |
| K131224 | Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…GAW · Special | Surgical Specialties Corp. Dba Angiotech | 05/16/2013SE |
| K130078 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignGAW · Traditional | Surgical Specialties Corp. Dba Angiotech | 02/28/2013SE |
| K113494 | Noblestitch El Noblestitch MR Noblestitch TaGAW · Special | Nobles Medical Technologies Ii, Inc. | 04/19/2012SE |
| K113763 | Srm-Stitch 8F Srm-Stitch 8F with GuidewireGAW · Special | Nobles Medical Technologies Ii, Inc. | 03/16/2012SE |
| K113800 | Quill Quadrahelix Tissue-Closure DeviceGAW · Special | Angiotech | 01/20/2012SE |
| K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and…GAW · Traditional | Lsi Solutions, Inc. | 10/13/2010SE |
| K093112 | Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model…GAW · Traditional | Coloplast Manufacturing Us, LLC | 02/01/2010SE |
| K070243 | Sutralene Polypropylene SuturesGAW · Abbreviated | Visionary Medical Supplies, Inc. | 04/17/2007SE |
| K061700 | Neotract AnchorGAW · Traditional | Neotract, Inc. | 10/26/2006SE |
| K060414 | Kolster Methods, Inc., Featherlift Silhouette SutureGAW · Traditional | Kmi Kolster Methods, Inc. | 10/23/2006SE |
| K062125 | Superstitch 5F, 12F, and ElGAW · Special | Sutura, Inc. | 10/19/2006SE |
| K053482 | Superstitch GW, Models 06-15-04-GW, 08-15-04-GWGAW · Special | Sutura, Inc. | 12/27/2005SE |
| K052701 | CoroleneGAW · Traditional | Peters Surgical | 12/13/2005SE |
| K052962 | Optimized Barb DesignGAW · Traditional | Surgical Specialties Corp | 12/06/2005SE |
| K052373 | Quill Nonabsorbable Polypropylene Barbed SutureGAW · Abbreviated | Quill Medical, Inc. | 09/26/2005SE |
| K041511 | Trulene Non-Absorbable Polypropylene Surgical SutureGAW · Traditional | Sutures India Private Limited | 06/03/2005SE |
| K050947 | Modification to: Modified Uss Polypropylene SutureGAW · Special | United States Surgical, A Division of Tyco Healthc | 06/01/2005SE |
| K043330 | Polypropilene Surgical SuturesGAW · Traditional | Demetech Corp. | 05/16/2005SE |
| K050548 | Contour Midface Opposing Uni-Directional ThreadsGAW · Traditional | Surgical Specialties Corp | 04/01/2005SE |
| K050247 | Contour Necklift ThreadsGAW · Traditional | Surgical Specialties Corp | 03/04/2005SE |
| K043591 | Featherlift Extended Aptos ThreadGAW · Traditional | Kmi Kolster Methods, Inc. | 03/04/2005SE |
| K042856 | Contour Forehead/Browlift ThreadGAW · Traditional | Surgical Specialties Corp | 12/03/2004SE |
| K042283 | UniproGAW · Traditional | United Medical Industries Co. , Ltd. | 12/01/2004SE |
| K041593 | Featherlift Extended Length Aptos ThreadGAW · Traditional | Surgical Specialties Corp | 09/20/2004SE |
| K021834 | Suture Fixation Device; Mesh Fixation DeviceGAW · Traditional | Mle, Inc. | 08/28/2002SE |
| K020940 | Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00XGAW · Special | Sutura, Inc. | 04/17/2002SE |
| K020265 | Serralene, Model Catalog No 1SGAW · Traditional | Serral, S.A. DE C.V. | 03/08/2002SE |
| K013683 | Modification to: Abbott Vascular Suture Anastomosis DeviceGAW · Special | Abbott Vascular, Inc. | 12/06/2001SE |
| K012865 | Superstitch Vascular Suturing DeviceGAW · Special | Sutura, Inc. | 09/25/2001SE |
| K010990 | Ams Sling Fixation SystemGAW · Traditional | American Medical Systems, Inc. | 06/22/2001SE |
| K010909 | Nonabsorbable Polypropylene Surgical SutureGAW · Special | Tyco Healthcare Group LP | 04/09/2001SE |
| K002999 | Grams Polypropylene Nonabsorbable SutureGAW · Traditional | Gramsmed, LLC | 12/18/2000SE |
| K002557 | Suture Welding System and Kit-(J-Tip Design)GAW · Traditional | Axya Medical, Inc. | 10/06/2000SE |
| K001703 | Perclose Vascular Suture Delivery DeviceGAW · Traditional | Abbott Vascular, Inc. | 10/03/2000SE |
| K002435 | Modification to Axya Medical, Inc. Bone Anchor System and Kit (Bak)GAW · Special | Axya Medical, Inc. | 08/24/2000SE |
| K001625 | Pronova Nonabsorbable Suture, UspGAW · Traditional | ETHICON, Inc. | 07/10/2000SE |
| K001185 | Polypropylene, Nonabsorbable Surgical Sutures UspGAW · Traditional | Cp Medical | 06/23/2000SN |
| K000537 | Polypropylene Nonabsorbable Surgical Sutures, UspGAW · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 04/27/2000SN |
| K993997 | PolypropyleneGAW · Traditional | Trading Consultants and Distributors Intl., Inc. | 02/04/2000SE |
| K994313 | Modification to Bone Anchor and Kit (Bak)GAW · Special | Axya Medical, Inc. | 01/13/2000SE |
| K992405 | Axya Medical Inc, Bone Anchor System and Kit- (Bak)GAW · Traditional | Axya Medical, Inc. | 09/22/1999SE |
| K983108 | Suture Welding System and Kit (SWK)GAW · Traditional | Axya Medical, Inc. | 11/27/1998SE |
| K980703 | Premilene Nonabsorbable Polypropylene Surgical SutureGAW · Traditional | Aesculap, Inc. | 05/04/1998SE |
| K961389 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | R. K. Medical L. L. C. | 06/18/1996SN |
| K961168 | ViewpointGAW · Traditional | Philips Medical Systems (Cleveland), Inc. | 05/16/1996SE |
| K960209 | CPR Heart PackGAW · Traditional | Custom Pack Reliability | 04/04/1996SE |
| K954808 | Ussc Polyproplene SutureGAW · Traditional | United States Surgical, A Division of Tyco Healthc | 02/27/1996SN |
| K953609 | ProdekGAW · Traditional | Sutures , Ltd. | 01/31/1996SN |
| K945701 | Surgilene(R) SuturesGAW · Traditional | Davis & Geck, Inc. | 01/24/1995SN |
| K931917 | Suture Non-Absorbable Synthetic PolypropyleneGAW · Traditional | Surgimetrics International, Ltd. | 03/03/1994SE |
| K931614 | Mopylen SutureGAW · Traditional | S. Jackson, Inc. | 12/17/1993SE |
| K930941 | Lukens Polypropylene Monofilament NonabsorbableGAW · Traditional | Lukens Medical Corp. | 12/17/1993SE |
| K930587 | Surgilene Polypropylene SutureGAW · Traditional | Davis & Geck, Inc. | 12/17/1993SE |
| K926588 | Revised Labeling for Polypropylene SutureGAW · Traditional | Look, Inc. | 12/17/1993SE |
| K922630 | MopylenGAW · Traditional | S. Jackson, Inc. | 10/20/1992SE |
| K920437 | Synthetic Absorbable Suture, UndyedGAW · Traditional | ETHICON, Inc. | 07/30/1992SE |
| K914588 | Grieshaber Snare Instrument and Snare CartridgeGAW · Traditional | Grieshaber & Co. | 06/11/1992SE |
| K911905 | Deknatel(R) Microflex Ophthal Poly Suture,ModifiedGAW · Traditional | Deknatel, Inc. | 07/02/1991SE |
| K903176 | Advance Suture Nonabsorbable Polypropylene SutureGAW · Traditional | Advance Suture, Inc. | 06/28/1991SE |
| K911189 | Sterile Polypropylene Monfil Nonabsorb Surg SutureGAW · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 04/25/1991SE |
| K904906 | Sharpoint Polypropylene Nonabsorb Surg Sutures UspGAW · Traditional | Chathamborough Research Group, Inc. | 12/24/1990SE |
| K903643 | Deknatel Microflex Ophthalmic Polypropylene SutureGAW · Traditional | Deknatel, Inc. | 12/24/1990SE |
| K903584 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | Look, Inc. | 10/11/1990SE |
| K902872 | Nonabsorbable Polypropylene Surgical Suture*GAW · Traditional | United States Surgical, A Division of Tyco Healthc | 09/27/1990SN |
PMA approvals
- P890002 Polypropylene Surgical Suture · Alcon Laboratories · 05/31/1989
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2922-2026 Class II | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2921-2026 Class II | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-1098-2025 Class II | ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in USSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine… | Ethicon, LLC | 12/20/2024Open, Classified |
| Z-1097-2025 Class II | PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is…Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine… | Ethicon, LLC | 12/20/2024Open, Classified |
| Z-1096-2025 Class II | PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is…Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine… | Ethicon, LLC | 12/20/2024Open, Classified |
| Z-1180-2023 Class II | Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-1179-2023 Class II | Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | Covidien, LP | 12/02/2022Open, Classified |
| Z-2466-2018 Class II | PRONOVA SUTURE BLUE 122CM M1.5, D10189The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2465-2018 Class II | PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2464-2018 Class II | PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2463-2018 Class II | PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2462-2018 Class II | PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2461-2018 Class II | PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2460-2018 Class II | PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2459-2018 Class II | PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2458-2018 Class II | PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2457-2018 Class II | PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2456-2018 Class II | PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2455-2018 Class II | PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2454-2018 Class II | PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2453-2018 Class II | PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2452-2018 Class II | PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2451-2018 Class II | PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2450-2018 Class II | PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2449-2018 Class II | PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2448-2018 Class II | PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031The needle associated with certain suture product codes has the potential to perforate the packaging due to… | Ethicon, Inc. | 05/07/2018Terminated |
| Z-2042-2016 Class II | Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558NSurgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may… | SSC- Surgical Specialties Corporation | 05/20/2016Terminated |
| Z-0808-2007 | Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable…Potential for sterility of product to be compromised. Suture package seals incomplete or missing. | C P Medical | 04/03/2007Terminated |