Panels › General, Plastic Surgery › Product code GAW · Class 2
Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation 878.5010
1510(k)s in 12 months (85 all time)
2recalls in 12 months (28 all time)
26recalls that name a 510(k)
Top companies in GAW
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 4 | 22 |
| Axya Medical, Inc. | 5 | 0 |
| Surgical Specialties Corp | 5 | 0 |
| Covidien, LP | 0 | 4 |
| Sutura, Inc. | 4 | 0 |
| Aesculap, Inc. | 3 | 0 |
| Nobles Medical Technologies Ii, Inc. | 3 | 0 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Abbott Vascular, Inc. | 2 | 0 |
| Angiotech | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2026 | K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotl ETHICON, Inc. | GAW |
| Jan 12, 2024 | K233355 | Cypris eXact Suturing System Cypris Medical | GAW |
| Sep 14, 2023 | K230746 | Non absorbable Surgical Polypropylene Suture Shandong Haidike Medical Products Co., Ltd., CN | GAW |
| Dec 9, 2022 | K221280 | Vesseal Lydus Medical , Ltd., IL | GAW |
| Sep 2, 2022 | K211178 | DURAMESH Mesh Suture Msi | GAW |
| Aug 27, 2020 | K192953 | APTOS Threads Polypropylene Surgical Sutures Aptos, LLC, GE | GAW |
| Mar 19, 2020 | K193530 | Deklene MAXX Teleflex Medical | GAW |
| Jun 14, 2019 | K191299 | Silhouette Featherlift / Silhouette Lift Silhouette Lift, Inc. | GAW |
| Dec 21, 2018 | K173747 | REXLENE Sm Eng Co., Ltd., KR | GAW |
| Mar 7, 2018 | K180321 | Aesculap Optilene Nonabsorbable Suture Aesculap, Inc. | GAW |
| Feb 15, 2018 | K173644 | Gazelle Polypropylene Suture and Delivery Device Dura Tap, LLC | GAW |
| Aug 29, 2017 | K171039 | Assut Filbloc Permanent Sutures Assut Europe S.P.A., IT | GAW |
| May 3, 2017 | K171005 | Silhouette Featherlift Silhouette Lift, Inc. | GAW |
| Apr 6, 2017 | K162617 | NobleStitch EL Nobles Medical Technologies Ii, Inc. | GAW |
| Sep 15, 2016 | K160529 | Pledgeted COR-SUTURE QUICK LOAD Lsi Soultions | GAW |
| Oct 29, 2015 | K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL Resorba Medical GmbH, DE | GAW |
| Sep 10, 2015 | K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design Angiotech | GAW |
| Jan 16, 2015 | K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM Edwards Lifesciences, LLC | GAW |
| Dec 16, 2014 | K142639 | StitchKit Origami Surgical, LLC | GAW |
| Jul 15, 2014 | K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE Aesculap, Inc. | GAW |
| Dec 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, Inc. | GAW |
| May 16, 2013 | K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE Surgical Specialties Corp. Dba Angiotech | GAW |
| Feb 28, 2013 | K130078 | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech | GAW |
| Apr 19, 2012 | K113494 | NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA Nobles Medical Technologies Ii, Inc. | GAW |
| Mar 16, 2012 | K113763 | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE Nobles Medical Technologies Ii, Inc. | GAW |
| Jan 20, 2012 | K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE Angiotech | GAW |
| Oct 13, 2010 | K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME Lsi Solutions, Inc. | GAW |
| Feb 1, 2010 | K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE Coloplast Manufacturing Us, LLC | GAW |
| Apr 17, 2007 | K070243 | SUTRALENE POLYPROPYLENE SUTURES Visionary Medical Supplies, Inc. | GAW |
| Oct 26, 2006 | K061700 | NEOTRACT ANCHOR Neotract, Inc. | GAW |
| Oct 23, 2006 | K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE Kmi Kolster Methods, Inc. | GAW |
| Oct 19, 2006 | K062125 | SUPERSTITCH 5F, 12F, AND EL Sutura, Inc. | GAW |
| Dec 27, 2005 | K053482 | SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW Sutura, Inc. | GAW |
| Dec 13, 2005 | K052701 | COROLENE Peters Surgical, FR | GAW |
| Dec 6, 2005 | K052962 | OPTIMIZED BARB DESIGN Surgical Specialties Corp | GAW |
| Sep 26, 2005 | K052373 | QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE Quill Medical, Inc. | GAW |
| Jun 3, 2005 | K041511 | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE Sutures India Private Limited, IN | GAW |
| Jun 1, 2005 | K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE United States Surgical, A Division of Tyco Healthc | GAW |
| May 16, 2005 | K043330 | POLYPROPILENE SURGICAL SUTURES Demetech Corp. | GAW |
| Apr 1, 2005 | K050548 | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS Surgical Specialties Corp | GAW |
| Mar 4, 2005 | K050247 | CONTOUR NECKLIFT THREADS Surgical Specialties Corp | GAW |
| Mar 4, 2005 | K043591 | FEATHERLIFT EXTENDED APTOS THREAD Kmi Kolster Methods, Inc. | GAW |
| Dec 3, 2004 | K042856 | CONTOUR FOREHEAD/BROWLIFT THREAD Surgical Specialties Corp | GAW |
| Dec 1, 2004 | K042283 | UNIPRO United Medical Industries Co. , Ltd., SA | GAW |
| Sep 20, 2004 | K041593 | FEATHERLIFT EXTENDED LENGTH APTOS THREAD Surgical Specialties Corp | GAW |
| Aug 28, 2002 | K021834 | SUTURE FIXATION DEVICE; MESH FIXATION DEVICE Mle, Inc. | GAW |
| Apr 17, 2002 | K020940 | SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X Sutura, Inc. | GAW |
| Mar 8, 2002 | K020265 | SERRALENE, MODEL CATALOG NO 1S Serral, S.A. DE C.V. | GAW |
| Dec 6, 2001 | K013683 | MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE Abbott Vascular, Inc. | GAW |
| Sep 25, 2001 | K012865 | SUPERSTITCH VASCULAR SUTURING DEVICE Sutura, Inc. | GAW |
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