Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAW — Predicate Candidate Screening
85 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
311 days90th percentile
85clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Co | ETHICON, Inc. | 2026-03-27 | 130 | 0 |
| K233355 | Cypris eXact Suturing System | Cypris Medical | 2024-01-12 | 105 | 0 |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 | 181 | 0 |
| K221280 | Vesseal | Lydus Medical , Ltd. | 2022-12-09 | 220 | 0 |
| K211178 | DURAMESH Mesh Suture | Msi | 2022-09-02 | 500 | 0 |
| K192953 | APTOS Threads – Polypropylene Surgical Sutures | Aptos, LLC | 2020-08-27 | 311 | 0 |
| K193530 | Deklene MAXX | Teleflex Medical | 2020-03-19 | 90 | 0 |
| K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | 2019-06-14 | 31 | 0 |
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018-12-21 | 378 | 0 |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018-03-07 | 30 | 0 |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | 2018-02-15 | 80 | 0 |
| K171039 | Assut Filbloc Permanent Sutures | Assut Europe S.P.A. | 2017-08-29 | 145 | 0 |
| K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | 2017-05-03 | 29 | 0 |
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | 2017-04-06 | 198 | 0 |
| K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016-09-15 | 203 | 0 |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMID | Resorba Medical GmbH | 2015-10-29 | 315 | 0 |
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable | Angiotech | 2015-09-10 | 135 | 0 |
| K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | Edwards Lifesciences, LLC | 2015-01-16 | 252 | 0 |
| K142639 | StitchKit | Origami Surgical, LLC | 2014-12-16 | 90 | 0 |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Aesculap, Inc. | 2014-07-15 | 207 | 0 |
| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | ETHICON, Inc. | 2013-12-06 | 36 | 2 |
| K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE | Surgical Specialties Corp. Dba Angiotech | 2013-05-16 | 16 | 0 |
| K130078 | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE | Surgical Specialties Corp. Dba Angiotech | 2013-02-28 | 45 | 0 |
| K113494 | NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA | Nobles Medical Technologies Ii, Inc. | 2012-04-19 | 146 | 0 |
| K113763 | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE | Nobles Medical Technologies Ii, Inc. | 2012-03-16 | 86 | 0 |
| K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE | Angiotech | 2012-01-20 | 28 | 0 |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLA | Lsi Solutions, Inc. | 2010-10-13 | 225 | 0 |
| K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE | Coloplast Manufacturing Us, LLC | 2010-02-01 | 123 | 0 |
| K070243 | SUTRALENE POLYPROPYLENE SUTURES | Visionary Medical Supplies, Inc. | 2007-04-17 | 82 | 0 |
| K061700 | NEOTRACT ANCHOR | Neotract, Inc. | 2006-10-26 | 132 | 0 |
| K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE | Kmi Kolster Methods, Inc. | 2006-10-23 | 249 | 1 |
| K062125 | SUPERSTITCH 5F, 12F, AND EL | Sutura, Inc. | 2006-10-19 | 86 | 0 |
| K053482 | SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW | Sutura, Inc. | 2005-12-27 | 13 | 0 |
| K052701 | COROLENE | Peters Surgical | 2005-12-13 | 76 | 0 |
| K052962 | OPTIMIZED BARB DESIGN | Surgical Specialties Corp | 2005-12-06 | 46 | 0 |
| K052373 | QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE | Quill Medical, Inc. | 2005-09-26 | 27 | 0 |
| K041511 | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-03 | 361 | 0 |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | United States Surgical, A Division of Tyco Healthc | 2005-06-01 | 47 | 2 |
| K043330 | POLYPROPILENE SURGICAL SUTURES | Demetech Corp. | 2005-05-16 | 165 | 0 |
| K050548 | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS | Surgical Specialties Corp | 2005-04-01 | 30 | 0 |
| K043591 | FEATHERLIFT EXTENDED APTOS THREAD | Kmi Kolster Methods, Inc. | 2005-03-04 | 66 | 0 |
| K050247 | CONTOUR NECKLIFT THREADS | Surgical Specialties Corp | 2005-03-04 | 30 | 0 |
| K042856 | CONTOUR FOREHEAD/BROWLIFT THREAD | Surgical Specialties Corp | 2004-12-03 | 60 | 0 |
| K042283 | UNIPRO | United Medical Industries Co. , Ltd. | 2004-12-01 | 99 | 0 |
| K041593 | FEATHERLIFT EXTENDED LENGTH APTOS THREAD | Surgical Specialties Corp | 2004-09-20 | 98 | 0 |
| K021834 | SUTURE FIXATION DEVICE; MESH FIXATION DEVICE | Mle, Inc. | 2002-08-28 | 85 | 0 |
| K020940 | SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15 | Sutura, Inc. | 2002-04-17 | 26 | 0 |
| K020265 | SERRALENE, MODEL CATALOG NO 1S | Serral, S.A. DE C.V. | 2002-03-08 | 42 | 0 |
| K013683 | MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE | Abbott Vascular, Inc. | 2001-12-06 | 29 | 0 |
| K012865 | SUPERSTITCH VASCULAR SUTURING DEVICE | Sutura, Inc. | 2001-09-25 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda