FDA Product Code
FDA Product Code GAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5010
510(k) Clearances — 85 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2026-03-27 | Traditional | PDF ↗ |
| K233355 | Cypris eXact Suturing System | Cypris Medical | 2024-01-12 | Traditional | PDF ↗ |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 | Traditional | PDF ↗ |
| K221280 | Vesseal | Lydus Medical , Ltd. | 2022-12-09 | Traditional | PDF ↗ |
| K211178 | DURAMESH Mesh Suture | Msi | 2022-09-02 | Traditional | PDF ↗ |
| K192953 | APTOS Threads Polypropylene Surgical Sutures | Aptos, LLC | 2020-08-27 | Traditional | PDF ↗ |
| K193530 | Deklene MAXX | Teleflex Medical | 2020-03-19 | Special | PDF ↗ |
| K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | 2019-06-14 | Special | PDF ↗ |
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018-12-21 | Traditional | PDF ↗ |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018-03-07 | Special | PDF ↗ |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | 2018-02-15 | Abbreviated | PDF ↗ |
| K171039 | Assut Filbloc Permanent Sutures | Assut Europe S.P.A. | 2017-08-29 | Abbreviated | PDF ↗ |
| K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | 2017-05-03 | Special | PDF ↗ |
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | 2017-04-06 | Abbreviated | PDF ↗ |
| K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016-09-15 | Abbreviated | PDF ↗ |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | Resorba Medical GmbH | 2015-10-29 | Traditional | PDF ↗ |
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Angiotech | 2015-09-10 | Special | PDF ↗ |
| K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | Edwards Lifesciences, LLC | 2015-01-16 | Traditional | PDF ↗ |
| K142639 | StitchKit | Origami Surgical, LLC | 2014-12-16 | Traditional | PDF ↗ |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Aesculap, Inc. | 2014-07-15 | Traditional | PDF ↗ |
| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | ETHICON, Inc. | 2013-12-06 | Special | PDF ↗ |
| K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | Surgical Specialties Corp. Dba Angiotech | 2013-05-16 | Special | PDF ↗ |
| K130078 | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corp. Dba Angiotech | 2013-02-28 | Traditional | PDF ↗ |
| K113494 | NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA | Nobles Medical Technologies Ii, Inc. | 2012-04-19 | Special | PDF ↗ |
| K113763 | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE | Nobles Medical Technologies Ii, Inc. | 2012-03-16 | Special | PDF ↗ |
| K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE | Angiotech | 2012-01-20 | Special | PDF ↗ |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME | Lsi Solutions, Inc. | 2010-10-13 | Traditional | PDF ↗ |
| K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE | Coloplast Manufacturing Us, LLC | 2010-02-01 | Traditional | PDF ↗ |
| K070243 | SUTRALENE POLYPROPYLENE SUTURES | Visionary Medical Supplies, Inc. | 2007-04-17 | Abbreviated | PDF ↗ |
| K061700 | NEOTRACT ANCHOR | Neotract, Inc. | 2006-10-26 | Traditional | PDF ↗ |
| K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE | Kmi Kolster Methods, Inc. | 2006-10-23 | Traditional | PDF ↗ |
| K062125 | SUPERSTITCH 5F, 12F, AND EL | Sutura, Inc. | 2006-10-19 | Special | PDF ↗ |
| K053482 | SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW | Sutura, Inc. | 2005-12-27 | Special | PDF ↗ |
| K052701 | COROLENE | Peters Surgical | 2005-12-13 | Traditional | PDF ↗ |
| K052962 | OPTIMIZED BARB DESIGN | Surgical Specialties Corp | 2005-12-06 | Traditional | PDF ↗ |
| K052373 | QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE | Quill Medical, Inc. | 2005-09-26 | Abbreviated | PDF ↗ |
| K041511 | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-03 | Traditional | PDF ↗ |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | United States Surgical, A Division of Tyco Healthc | 2005-06-01 | Special | PDF ↗ |
| K043330 | POLYPROPILENE SURGICAL SUTURES | Demetech Corp. | 2005-05-16 | Traditional | PDF ↗ |
| K050548 | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS | Surgical Specialties Corp | 2005-04-01 | Traditional | PDF ↗ |
| K050247 | CONTOUR NECKLIFT THREADS | Surgical Specialties Corp | 2005-03-04 | Traditional | PDF ↗ |
| K043591 | FEATHERLIFT EXTENDED APTOS THREAD | Kmi Kolster Methods, Inc. | 2005-03-04 | Traditional | PDF ↗ |
| K042856 | CONTOUR FOREHEAD/BROWLIFT THREAD | Surgical Specialties Corp | 2004-12-03 | Traditional | PDF ↗ |
| K042283 | UNIPRO | United Medical Industries Co. , Ltd. | 2004-12-01 | Traditional | PDF ↗ |
| K041593 | FEATHERLIFT EXTENDED LENGTH APTOS THREAD | Surgical Specialties Corp | 2004-09-20 | Traditional | PDF ↗ |
| K021834 | SUTURE FIXATION DEVICE; MESH FIXATION DEVICE | Mle, Inc. | 2002-08-28 | Traditional | PDF ↗ |
| K020940 | SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X | Sutura, Inc. | 2002-04-17 | Special | PDF ↗ |
| K020265 | SERRALENE, MODEL CATALOG NO 1S | Serral, S.A. DE C.V. | 2002-03-08 | Traditional | PDF ↗ |
| K013683 | MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE | Abbott Vascular, Inc. | 2001-12-06 | Special | PDF ↗ |
| K012865 | SUPERSTITCH VASCULAR SUTURING DEVICE | Sutura, Inc. | 2001-09-25 | Special | PDF ↗ |
| K010990 | AMS SLING FIXATION SYSTEM | American Medical Systems, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K010909 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE | Tyco Healthcare Group LP | 2001-04-09 | Special | PDF ↗ |
| K002999 | GRAMS POLYPROPYLENE NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-18 | Traditional | PDF ↗ |
| K002557 | SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) | Axya Medical, Inc. | 2000-10-06 | Traditional | PDF ↗ |
| K001703 | PERCLOSE VASCULAR SUTURE DELIVERY DEVICE | Abbott Vascular, Inc. | 2000-10-03 | Traditional | PDF ↗ |
| K002435 | MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) | Axya Medical, Inc. | 2000-08-24 | Special | PDF ↗ |
| K001625 | PRONOVA NONABSORBABLE SUTURE, USP | ETHICON, Inc. | 2000-07-10 | Traditional | PDF ↗ |
| K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 | Traditional | PDF ↗ |
| K000537 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | Traditional | PDF ↗ |
| K993997 | POLYPROPYLENE | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K994313 | MODIFICATION TO BONE ANCHOR AND KIT (BAK) | Axya Medical, Inc. | 2000-01-13 | Special | PDF ↗ |
| K992405 | AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) | Axya Medical, Inc. | 1999-09-22 | Traditional | PDF ↗ |
| K983108 | SUTURE WELDING SYSTEM AND KIT (SWK) | Axya Medical, Inc. | 1998-11-27 | Traditional | PDF ↗ |
| K980703 | PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE | Aesculap, Inc. | 1998-05-04 | Traditional | PDF ↗ |
| K961389 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | R. K. Medical L. L. C. | 1996-06-18 | Traditional | PDF ↗ |
| K961168 | VIEWPOINT | Philips Medical Systems (Cleveland), Inc. | 1996-05-16 | Traditional | PDF ↗ |
| K960209 | CPR HEART PACK | Custom Pack Reliability | 1996-04-04 | Traditional | PDF ↗ |
| K954808 | USSC POLYPROPLENE SUTURE | United States Surgical, A Division of Tyco Healthc | 1996-02-27 | Traditional | PDF ↗ |
| K953609 | PRODEK | Sutures , Ltd. | 1996-01-31 | Traditional | PDF ↗ |
| K945701 | SURGILENE(R) SUTURES | Davis & Geck, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K931917 | SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE | Surgimetrics International, Ltd. | 1994-03-03 | Traditional | PDF ↗ |
| K926588 | REVISED LABELING FOR POLYPROPYLENE SUTURE | Look, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K931614 | MOPYLEN SUTURE | S. Jackson, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K930941 | LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE | Lukens Medical Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K930587 | SURGILENE POLYPROPYLENE SUTURE | Davis & Geck, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K922630 | MOPYLEN | S. Jackson, Inc. | 1992-10-20 | Traditional | PDF ↗ |
| K920437 | SYNTHETIC ABSORBABLE SUTURE, UNDYED | ETHICON, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K914588 | GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE | Grieshaber & Co. | 1992-06-11 | Traditional | PDF ↗ |
| K911905 | DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED | Deknatel, Inc. | 1991-07-02 | Traditional | PDF ↗ |
| K903176 | ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE | Advance Suture, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K911189 | STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE | Internacional Farmaceutica, S.A. DE C.V. | 1991-04-25 | Traditional | PDF ↗ |
| K904906 | SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP | Chathamborough Research Group, Inc. | 1990-12-24 | Traditional | PDF ↗ |
| K903643 | DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE | Deknatel, Inc. | 1990-12-24 | Traditional | PDF ↗ |
| K903584 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | Look, Inc. | 1990-10-11 | Traditional | PDF ↗ |
| K902872 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE* | United States Surgical, A Division of Tyco Healthc | 1990-09-27 | Traditional | PDF ↗ |
Product code GAW · Class II · General, Plastic Surgery. Data: openFDA.