Atlas FDA

GAW

85 FDA 510(k) clearances · Product code

84 daysmedian time to decision
311 days90th percentile
85clearances measured

FDA profile

Official device name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5010
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 1,652 · 2022: 1,563 · 2023: 1,811 · 2024: 2,348 · 2025: 2,583 · 2026: 1,538
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (K253572)ETHICON, Inc.2026-03-27
Cypris eXact Suturing System (K233355)Cypris Medical2024-01-12
Non absorbable Surgical Polypropylene Suture (K230746)Shandong Haidike Medical Products Co., Ltd.2023-09-14
Vesseal (K221280)Lydus Medical , Ltd.2022-12-09
DURAMESH Mesh Suture (K211178)Msi2022-09-02
APTOS Threads – Polypropylene Surgical Sutures (K192953)Aptos, LLC2020-08-27
Deklene MAXX (K193530)Teleflex Medical2020-03-19
Silhouette Featherlift / Silhouette Lift (K191299)Silhouette Lift, Inc.2019-06-14
REXLENE (K173747)Sm Eng Co., Ltd.2018-12-21
Aesculap Optilene Nonabsorbable Suture (K180321)Aesculap, Inc.2018-03-07
Gazelle Polypropylene Suture and Delivery Device (K173644)Dura Tap, LLC2018-02-15
Assut Filbloc Permanent Sutures (K171039)Assut Europe S.P.A.2017-08-29
Silhouette Featherlift (K171005)Silhouette Lift, Inc.2017-05-03
NobleStitch EL (K162617)Nobles Medical Technologies Ii, Inc.2017-04-06
Pledgeted COR-SUTURE QUICK LOAD (K160529)Lsi Soultions2016-09-15
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL (K143582)Resorba Medical GmbH2015-10-29
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (K151112)Angiotech2015-09-10
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM (K141206)Edwards Lifesciences, LLC2015-01-16
StitchKit (K142639)Origami Surgical, LLC2014-12-16
AESCULAP OPTILENE NONABSORBABLE SUTURE (K133890)Aesculap, Inc.2014-07-15
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE (K133356)ETHICON, Inc.2013-12-06
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE (K131224)Surgical Specialties Corp. Dba Angiotech2013-05-16
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K130078)Surgical Specialties Corp. Dba Angiotech2013-02-28
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA (K113494)Nobles Medical Technologies Ii, Inc.2012-04-19
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE (K113763)Nobles Medical Technologies Ii, Inc.2012-03-16
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (K113800)Angiotech2012-01-20
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME (K100593)Lsi Solutions, Inc.2010-10-13
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE (K093112)Coloplast Manufacturing Us, LLC2010-02-01
SUTRALENE POLYPROPYLENE SUTURES (K070243)Visionary Medical Supplies, Inc.2007-04-17
NEOTRACT ANCHOR (K061700)Neotract, Inc.2006-10-26
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE (K060414)Kmi Kolster Methods, Inc.2006-10-23
SUPERSTITCH 5F, 12F, AND EL (K062125)Sutura, Inc.2006-10-19
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW (K053482)Sutura, Inc.2005-12-27
COROLENE (K052701)Peters Surgical2005-12-13
OPTIMIZED BARB DESIGN (K052962)Surgical Specialties Corp2005-12-06
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE (K052373)Quill Medical, Inc.2005-09-26
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K041511)Sutures India Private Limited2005-06-03
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (K050947)United States Surgical, A Division of Tyco Healthc2005-06-01
POLYPROPILENE SURGICAL SUTURES (K043330)Demetech Corp.2005-05-16
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS (K050548)Surgical Specialties Corp2005-04-01
FEATHERLIFT EXTENDED APTOS THREAD (K043591)Kmi Kolster Methods, Inc.2005-03-04
CONTOUR NECKLIFT THREADS (K050247)Surgical Specialties Corp2005-03-04
CONTOUR FOREHEAD/BROWLIFT THREAD (K042856)Surgical Specialties Corp2004-12-03
UNIPRO (K042283)United Medical Industries Co. , Ltd.2004-12-01
FEATHERLIFT EXTENDED LENGTH APTOS THREAD (K041593)Surgical Specialties Corp2004-09-20
SUTURE FIXATION DEVICE; MESH FIXATION DEVICE (K021834)Mle, Inc.2002-08-28
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X (K020940)Sutura, Inc.2002-04-17
SERRALENE, MODEL CATALOG NO 1S (K020265)Serral, S.A. DE C.V.2002-03-08
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE (K013683)Abbott Vascular, Inc.2001-12-06
SUPERSTITCH VASCULAR SUTURING DEVICE (K012865)Sutura, Inc.2001-09-25
AMS SLING FIXATION SYSTEM (K010990)American Medical Systems, Inc.2001-06-22
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K010909)Tyco Healthcare Group LP2001-04-09
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE (K002999)Gramsmed, LLC2000-12-18
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) (K002557)Axya Medical, Inc.2000-10-06
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE (K001703)Abbott Vascular, Inc.2000-10-03
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) (K002435)Axya Medical, Inc.2000-08-24
PRONOVA NONABSORBABLE SUTURE, USP (K001625)ETHICON, Inc.2000-07-10
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP (K001185)Cp Medical2000-06-23
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (K000537)Arc Medical Supplies (Beijing) Co, Ltd.2000-04-27
POLYPROPYLENE (K993997)Trading Consultants and Distributors Intl., Inc.2000-02-04
MODIFICATION TO BONE ANCHOR AND KIT (BAK) (K994313)Axya Medical, Inc.2000-01-13
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) (K992405)Axya Medical, Inc.1999-09-22
SUTURE WELDING SYSTEM AND KIT (SWK) (K983108)Axya Medical, Inc.1998-11-27
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K980703)Aesculap, Inc.1998-05-04
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (K961389)R. K. Medical L. L. C.1996-06-18
VIEWPOINT (K961168)Philips Medical Systems (Cleveland), Inc.1996-05-16
CPR HEART PACK (K960209)Custom Pack Reliability1996-04-04
USSC POLYPROPLENE SUTURE (K954808)United States Surgical, A Division of Tyco Healthc1996-02-27
PRODEK (K953609)Sutures , Ltd.1996-01-31
SURGILENE(R) SUTURES (K945701)Davis & Geck, Inc.1995-01-24
SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE (K931917)Surgimetrics International, Ltd.1994-03-03
SURGILENE POLYPROPYLENE SUTURE (K930587)Davis & Geck, Inc.1993-12-17
LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE (K930941)Lukens Medical Corp.1993-12-17
MOPYLEN SUTURE (K931614)S. Jackson, Inc.1993-12-17
REVISED LABELING FOR POLYPROPYLENE SUTURE (K926588)Look, Inc.1993-12-17
MOPYLEN (K922630)S. Jackson, Inc.1992-10-20
SYNTHETIC ABSORBABLE SUTURE, UNDYED (K920437)ETHICON, Inc.1992-07-30
GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE (K914588)Grieshaber & Co.1992-06-11
DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED (K911905)Deknatel, Inc.1991-07-02
ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE (K903176)Advance Suture, Inc.1991-06-28
STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE (K911189)Internacional Farmaceutica, S.A. DE C.V.1991-04-25
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE (K903643)Deknatel, Inc.1990-12-24
SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP (K904906)Chathamborough Research Group, Inc.1990-12-24
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (K903584)Look, Inc.1990-10-11
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE* (K902872)United States Surgical, A Division of Tyco Healthc1990-09-27

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