Product code GAW
- Device name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5010
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P820083S025 | GORE-TEX(TM) SUTURE | W. L. Gore & Associates, Inc. | 1998-08-27 |
| P820083S024 | GORE-TEX(TM) SUTURE | W. L. Gore & Associates, Inc. | 1996-10-03 |
| P820083S023 | GORE-TEX(TM) SUTURE | W. L. Gore & Associates, Inc. | 1996-10-03 |
| P820083S022 | GORE-TEX SUTURE WITH PLEDGETS | W. L. Gore & Associates, Inc. | 1996-09-24 |
| P820083S021 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1996-09-24 |
| P820083S020 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1995-06-05 |
| P820083S019 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1995-01-23 |
| P820083S017 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1994-08-19 |
| P820083S018 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1994-08-11 |
| P820083S015 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1994-04-08 |
| P820083S016 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1994-01-10 |
| P820083S014 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1993-10-15 |
| P820083S013 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1993-07-01 |
| P820083S012 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1990-10-19 |
| P890002 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories | 1989-05-31 |
| P820083S010 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989-05-26 |
| P820083S008 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989-05-02 |
| P820083S009 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989-03-09 |
| P820083S007 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989-03-09 |
| P820083S006 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1987-12-14 |
| P820083S005 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1987-07-31 |
| P820083S004 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1986-08-05 |
| P820083S003 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1986-06-09 |
| P820083S002 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1986-06-05 |
| P820083S001 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1986-05-12 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2026-03-27 |
| K233355 | Cypris eXact Suturing System | Cypris Medical | 2024-01-12 |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 |
| K221280 | Vesseal | Lydus Medical , Ltd. | 2022-12-09 |
| K211178 | DURAMESH Mesh Suture | Msi | 2022-09-02 |
| K192953 | APTOS Threads – Polypropylene Surgical Sutures | Aptos, LLC | 2020-08-27 |
| K193530 | Deklene MAXX | Teleflex Medical | 2020-03-19 |
| K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | 2019-06-14 |
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018-12-21 |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018-03-07 |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | 2018-02-15 |
| K171039 | Assut Filbloc Permanent Sutures | Assut Europe S.P.A. | 2017-08-29 |
| K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | 2017-05-03 |
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | 2017-04-06 |
| K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016-09-15 |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | Resorba Medical GmbH | 2015-10-29 |
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Angiotech | 2015-09-10 |
| K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | Edwards Lifesciences, LLC | 2015-01-16 |
| K142639 | StitchKit | Origami Surgical, LLC | 2014-12-16 |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Aesculap, Inc. | 2014-07-15 |
| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | ETHICON, Inc. | 2013-12-06 |
| K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | Surgical Specialties Corp. Dba Angiotech | 2013-05-16 |
| K130078 | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corp. Dba Angiotech | 2013-02-28 |
| K113494 | NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA | Nobles Medical Technologies Ii, Inc. | 2012-04-19 |
| K113763 | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE | Nobles Medical Technologies Ii, Inc. | 2012-03-16 |
| K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE | Angiotech | 2012-01-20 |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME | Lsi Solutions, Inc. | 2010-10-13 |
| K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE | Coloplast Manufacturing Us, LLC | 2010-02-01 |
| K070243 | SUTRALENE POLYPROPYLENE SUTURES | Visionary Medical Supplies, Inc. | 2007-04-17 |
| K061700 | NEOTRACT ANCHOR | Neotract, Inc. | 2006-10-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07757093025290 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093025184 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093025146 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093025115 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093025092 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093024873 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093024859 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093024828 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093024767 | SUTUMED | Unilene S.A.C. | 2023-01-09 |
| 07757093024385 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024682 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024675 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024583 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024576 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024439 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024361 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024330 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024255 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024217 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024125 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024118 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024101 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093024033 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093023968 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093023890 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093023869 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093023838 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093023760 | SUTUMED | Unilene S.A.C. | 2023-01-07 |
| 07757093023470 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093023500 | SUTUMED | Unilene S.A.C. | 2023-01-06 |