FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K013683 |
ABBOTT VASCULAR INC. |
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE |
12/06/2001 |
K001703 |
ABBOTT VASCULAR INC. |
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE |
10/03/2000 |
K133890 |
AESCULAP, INC. |
AESCULAP OPTILENE NONABSORBABLE SUTURE |
07/15/2014 |
K180321 |
Aesculap, Inc. |
Aesculap Optilene Nonabsorbable Suture |
03/07/2018 |
K980703 |
AESCULAP, INC. |
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
05/04/1998 |
K010990 |
AMERICAN MEDICAL SYSTEMS, INC. |
AMS SLING FIXATION SYSTEM |
06/22/2001 |
K151112 |
ANGIOTECH |
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design |
09/10/2015 |
K113800 |
ANGIOTECH |
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE |
01/20/2012 |
K192953 |
APTOS, LLC. |
APTOS Threads û Polypropylene Surgical Sutures |
08/27/2020 |
K000537 |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP |
04/27/2000 |
K171039 |
Assut Europe S.p.A. |
Assut Filbloc Permanent Sutures |
08/29/2017 |
K992405 |
AXYA MEDICAL, INC. |
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) |
09/22/1999 |
K002435 |
AXYA MEDICAL, INC. |
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) |
08/24/2000 |
K994313 |
AXYA MEDICAL, INC. |
MODIFICATION TO BONE ANCHOR AND KIT (BAK) |
01/13/2000 |
K983108 |
AXYA MEDICAL, INC. |
SUTURE WELDING SYSTEM AND KIT (SWK) |
11/27/1998 |
K002557 |
AXYA MEDICAL, INC. |
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) |
10/06/2000 |
K093112 |
COLOPLAST MANUFACTURING US, LLC |
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE |
02/01/2010 |
K001185 |
CP MEDICAL |
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP |
06/23/2000 |
K960209 |
CUSTOM PACK RELIABILITY |
CPR HEART PACK |
04/04/1996 |
K043330 |
DEMETECH CORP. |
POLYPROPILENE SURGICAL SUTURES |
05/16/2005 |
K173644 |
Dura Tap LLC |
Gazelle Polypropylene Suture and Delivery Device |
02/15/2018 |
K141206 |
EDWARDS LIFESCIENCES LLC. |
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM |
01/16/2015 |
K133356 |
ETHICON, INC. |
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE |
12/06/2013 |
K001625 |
ETHICON, INC. |
PRONOVA NONABSORBABLE SUTURE, USP |
07/10/2000 |
K002999 |
GRAMSMED LLC |
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE |
12/18/2000 |
K043591 |
KMI KOLSTER METHODS, INC. |
FEATHERLIFT EXTENDED APTOS THREAD |
03/04/2005 |
K060414 |
KMI KOLSTER METHODS, INC. |
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE |
10/23/2006 |
K100593 |
LSI SOLUTIONS, INC. |
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME |
10/13/2010 |
K160529 |
LSI SOULTIONS |
Pledgeted COR-SUTURE QUICK LOAD |
09/15/2016 |
K221280 |
Lydus Medical Ltd. |
Vesseal |
12/09/2022 |
K021834 |
MLE, INC. |
SUTURE FIXATION DEVICE; MESH FIXATION DEVICE |
08/28/2002 |
K211178 |
MSi |
DURAMESH Mesh Suture |
09/02/2022 |
K061700 |
NEOTRACT, INC. |
NEOTRACT ANCHOR |
10/26/2006 |
K162617 |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
NobleStitch EL |
04/06/2017 |
K113494 |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA |
04/19/2012 |
K113763 |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE |
03/16/2012 |
K142639 |
ORIGAMI SURGICAL LLC |
StitchKit |
12/16/2014 |
K052701 |
PETERS SURGICAL |
COROLENE |
12/13/2005 |
K961168 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
VIEWPOINT |
05/16/1996 |
K052373 |
QUILL MEDICAL, INC. |
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE |
09/26/2005 |
K961389 |
R.K. MEDICAL, L.L.C. |
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES |
06/18/1996 |
K143582 |
RESORBA MEDICAL GMBH |
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL |
10/29/2015 |
K020265 |
SERRAL, S.A. DE C.V. |
SERRALENE, MODEL CATALOG NO 1S |
03/08/2002 |
K230746 |
Shandong Haidike Medical Products Co.,Ltd. |
Non absorbable Surgical Polypropylene Suture |
09/14/2023 |
K171005 |
Silhouette Lift Inc. |
Silhouette Featherlift |
05/03/2017 |
K191299 |
Silhouette Lift Inc. |
Silhouette Featherlift / Silhouette Lift |
06/14/2019 |
K173747 |
SM ENG CO., LTD |
REXLENE |
12/21/2018 |
K042856 |
SURGICAL SPECIALTIES CORP. |
CONTOUR FOREHEAD/BROWLIFT THREAD |
12/03/2004 |
K050548 |
SURGICAL SPECIALTIES CORP. |
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS |
04/01/2005 |
K050247 |
SURGICAL SPECIALTIES CORP. |
CONTOUR NECKLIFT THREADS |
03/04/2005 |
K041593 |
SURGICAL SPECIALTIES CORP. |
FEATHERLIFT EXTENDED LENGTH APTOS THREAD |
09/20/2004 |
K052962 |
SURGICAL SPECIALTIES CORP. |
OPTIMIZED BARB DESIGN |
12/06/2005 |
K130078 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
02/28/2013 |
K131224 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE |
05/16/2013 |
K062125 |
SUTURA, INC. |
SUPERSTITCH 5F, 12F, AND EL |
10/19/2006 |
K053482 |
SUTURA, INC. |
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW |
12/27/2005 |
K012865 |
SUTURA, INC. |
SUPERSTITCH VASCULAR SUTURING DEVICE |
09/25/2001 |
K020940 |
SUTURA, INC. |
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X |
04/17/2002 |
K041511 |
SUTURES INDIA PRIVATE LIMITED |
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
06/03/2005 |
K953609 |
SUTURES LTD. |
PRODEK |
01/31/1996 |
K193530 |
Teleflex Medical |
Deklene MAXX |
03/19/2020 |
K993997 |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
POLYPROPYLENE |
02/04/2000 |
K010909 |
TYCO HEALTHCARE GROUP, LP |
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
04/09/2001 |
K042283 |
UNITED MEDICAL INDUSTRIES CO. LTD. |
UNIPRO |
12/01/2004 |
K050947 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE |
06/01/2005 |
K954808 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
USSC POLYPROPLENE SUTURE |
02/27/1996 |
K070243 |
VISIONARY MEDICAL SUPPLIES, INC. |
SUTRALENE POLYPROPYLENE SUTURES |
04/17/2007 |