FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K122734 |
AESCULAP, INC. |
AESCULAP NOVOSYN ABSORBABLE SUTURE |
12/18/2012 |
K011372 |
AESCULAP, INC. |
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
08/01/2001 |
K011375 |
AESCULAP, INC. |
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE |
06/29/2001 |
K171001 |
Aesculap, Inc. |
Monosyn Quick Synthetic Absorbable Surgical Suture |
10/23/2017 |
K170661 |
Aesculap, Inc. |
Novosyn Quick Absorbable Suture |
06/08/2017 |
K031286 |
AESCULAP, INC. |
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
05/29/2003 |
K980704 |
AESCULAP, INC. |
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE |
05/11/1998 |
K022664 |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. |
09/10/2002 |
K021767 |
ASSUT EUROPE S.P.A. |
ASSUFIL |
11/19/2002 |
K140039 |
AUROLAB |
POLYCRYL |
09/15/2014 |
K013177 |
BONUTTI RESEARCH, INC. |
MULTITAK SUTURE SNAP SYSTEM |
12/19/2001 |
K032698 |
COAPT SYSTEMS, INC. |
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE |
10/23/2003 |
K050611 |
COAPT SYSTEMS, INC. |
ENDOTINE RIBBON |
04/06/2005 |
K051415 |
COAPT SYSTEMS, INC. |
ENDOTINE RIBBON |
06/23/2005 |
K060828 |
COAPT SYSTEMS, INC. |
MODIFICATION TO ENDOTINE RIBBON |
04/19/2006 |
K111442 |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... |
06/03/2011 |
K072229 |
CP MEDICAL |
MONOSWIFT |
10/05/2007 |
K002190 |
CP MEDICAL |
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) |
08/10/2000 |
K023710 |
CP MEDICAL |
VISORB SWIFT |
01/17/2003 |
K170166 |
CPT Sutures Co., Ltd. |
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture |
09/29/2017 |
K980610 |
DAVIS & GECK, INC. |
DEXON RAPID (DEXON R) |
05/18/1998 |
K972566 |
DAVIS & GECK, INC. |
DEXON VIOLET |
08/14/1997 |
K130083 |
DEMETECH CORP. |
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE |
07/17/2013 |
K123940 |
DEMETECH CORP. |
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE |
05/30/2014 |
K043539 |
DEMETECH CORP. |
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES |
04/06/2005 |
K050771 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
LUPINE LOOP |
04/08/2005 |
K042233 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE |
09/28/2004 |
K041806 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP |
08/03/2004 |
K201996 |
Ethicon Inc. |
Monocryl Plus Antibacterial Suture |
12/21/2020 |
K192580 |
Ethicon, Inc |
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device |
12/18/2019 |
K181652 |
Ethicon, Inc. |
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture |
09/28/2018 |
K022715 |
ETHICON, INC. |
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE |
12/19/2002 |
K132580 |
ETHICON, INC. |
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE |
02/28/2014 |
K962480 |
ETHICON, INC. |
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED |
08/02/1996 |
K022269 |
ETHICON, INC. |
COATED VICRYL* (POLYGLACTIN 910) SUTURE |
09/13/2002 |
K161726 |
ETHICON, INC. |
E-Pack Procedure Kit |
07/12/2016 |
K964345 |
ETHICON, INC. |
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED |
12/16/1996 |
K032420 |
ETHICON, INC. |
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE |
10/22/2003 |
K033746 |
ETHICON, INC. |
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE |
12/18/2003 |
K970317 |
ETHICON, INC. |
MODIFIED E-PACK PROCEDURE KIT |
04/25/1997 |
K050845 |
ETHICON, INC. |
MONOCRYL PLUS ANTIBACTERIAL SUTURE |
06/29/2005 |
K974299 |
ETHICON, INC. |
PANACRYL |
02/13/1998 |
K142822 |
ETHICON, Inc. |
PLIASURE Polyglycolide Synthetic Absorbable Suture |
03/26/2015 |
K151200 |
ETHICON, INC. |
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
08/13/2015 |
K221744 |
Ethicon, Inc. |
STRATAFIXÖ Spiral MONOCRYLÖ Plus Knotless Tissue Control Device |
11/15/2022 |
K183183 |
Ethicon, Inc. |
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture |
06/27/2019 |
K153611 |
Ethicon, LLC |
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device |
06/03/2016 |
K183004 |
Foosin Medical Supplies Inc., Ltd |
WEGO-PGA RAPID |
01/28/2019 |
K183001 |
Foosin Medical Supplies Inc., Ltd |
WEGO-PGLA RAPID |
01/28/2019 |
K130737 |
FOOSIN MEDICAL SUPPLIES INC.LTD |
SYNTHETIC ABSORBABLE SUTURE |
01/14/2014 |
K130735 |
FOOSIN MEDICAL SUPPLIES INC.LTD |
SYNTHETIC ABSORBABLE SUTURE |
01/14/2014 |
K142810 |
FOOSIN MEDICAL SUPPLIES INC.LTD |
WEGO-PGCL Absorbable Surgical Monofilament Suture |
11/14/2014 |
K992088 |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
09/03/1999 |
K991191 |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
06/22/1999 |
K160564 |
GORDIAN SURGICAL LTD. |
TroClose1200 |
11/17/2016 |
K171494 |
Gordian Surgical Ltd. |
TroClose1200, TroClose1200 Cannula |
06/15/2017 |
K003017 |
GRAMSMED LLC |
GRAMSORB SYNTHETIC ABSORBABLE SUTURE |
03/13/2001 |
K010672 |
GRAMSMED LLC |
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE |
05/18/2001 |
K040282 |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID |
04/29/2004 |
K072863 |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES |
05/23/2008 |
K072859 |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES |
05/23/2008 |
K965162 |
LUKENS MEDICAL CORP. |
LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. |
02/12/1997 |
K172659 |
M/s. Meril Endo Surgery Private Limited |
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(gly |
09/28/2017 |
K150717 |
M/s. Meril Endo Surgery Private Limited |
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron |
10/14/2015 |
K053636 |
MANI, INC. |
MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) |
03/14/2006 |
K051700 |
MEDCHANNEL, LLC |
OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR |
08/15/2005 |
K971208 |
MEDLINE INDUSTRIES, INC. |
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS |
05/13/1997 |
K002639 |
MITEK PRODUCTS |
BIOKNOTLESS ANCHOR |
05/11/2001 |
K173043 |
Nantong Holycon Medical Devices Co., Ltd. |
Holycon Synthetic Absorbable Sutures |
12/14/2017 |
K063462 |
NEAT STITCH LTD. |
NEATSTITCH NEATCLOSE SUTURING DEVICE |
01/12/2007 |
K202950 |
Origami Surgical |
StitchKit COMBO |
02/23/2021 |
K211792 |
Origami Surgical Inc . |
StitchKit |
07/16/2021 |
K221527 |
Origami Surgical Inc . |
StitchKit |
02/14/2023 |
K173874 |
Origami Surgical LLC |
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO |
05/04/2018 |
K062366 |
PETERS SURGICAL |
OPTIME, SINUSORB PGA |
10/02/2006 |
K181320 |
Resorba Medical GmbH |
Caprolon |
09/18/2018 |
K143584 |
RESORBA MEDICAL GMBH |
PGA RESORBA, PGA RESOQUICK, GLYCOLON |
11/02/2015 |
K120556 |
RIVERPOINT MEDICAL |
VILET VILET QUICK |
05/23/2012 |
K180625 |
RK Manufacturing Corporation |
Rondek PGA Suture (Beige or Violet) |
05/10/2018 |
K984374 |
SAMYANG CORP. |
SURGISORB |
06/04/1999 |
K212810 |
Samyang Holdings Corp., Ltd. |
MONOFIX PGCL, knotless wound closure device |
08/05/2022 |
K033762 |
SERRAL, S.A. DE C.V. |
SERRALAPG |
03/15/2004 |
K080412 |
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD. |
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) |
09/04/2008 |
K200140 |
Silhouette Lift Inc. |
Silhouette Instalift |
03/27/2020 |
K142061 |
SILHOUETTE LIFT, INC. |
SILHOUETTE INSTALIFT |
04/24/2015 |
K163676 |
SILHOUETTE LIFT, INC. |
Silhouette InstaLift |
06/16/2017 |
K161629 |
SM ENG CO., LTD |
CRYLREX |
02/10/2017 |
K173779 |
SM ENG CO., LTD |
REXMONO, PDREX |
03/12/2018 |
K200392 |
SM ENG CO., LTD |
REXSIN |
07/07/2020 |
K093408 |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
11/12/2009 |
K100257 |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
VLOC9ABSORBABLE WOUND CLOSURE DEVICE |
05/10/2010 |
K091087 |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
04/22/2009 |
K082662 |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
03/26/2009 |
K052437 |
SURGICAL SPECIALTIES CORP. |
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE |
11/07/2005 |
K040477 |
SURGICAL SPECIALTIES CORP. |
MONODERM |
05/18/2004 |
K140227 |
SURGICAL SPECIALTIES CORP. |
MONODERM SURGICAL SUTURE |
02/28/2014 |
K141625 |
SURGICAL SPECIALTIES CORP. |
POLYSYN SURGICAL SUTURE |
07/18/2014 |
K141558 |
SURGICAL SPECIALTIES CORP. |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE |
07/11/2014 |
K072028 |
SURGICAL SPECIALTIES CORP. |
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM |
08/03/2007 |
K014021 |
SURGICAL SPECIALTIES CORP. |
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED |
01/28/2002 |
K122898 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
10/22/2012 |
K123409 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
11/20/2012 |
K123836 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
12/21/2012 |
K141778 |
SURGICAL SPECIALTIES CORPORATION |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
07/30/2014 |
K041515 |
SUTURES INDIA PRIVATE LIMITED |
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE |
04/08/2005 |
K081002 |
SUTURES INDIA PVT., LTD. |
MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE |
06/09/2008 |
K081003 |
SUTURES INDIA PVT., LTD. |
TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE |
06/09/2008 |
K990432 |
SUTURES LTD. |
SURGISORB |
05/27/1999 |
K060801 |
TELEFLEX MEDICAL |
DEKNA-LOK MODEL BP1000V2L |
05/17/2006 |
K033115 |
TELEFLEX MEDICAL |
ORTHODEK |
11/17/2003 |
K042141 |
TELEFLEX MEDICAL |
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE |
09/28/2004 |
K994001 |
TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
POLYGLYCOLIC ACID |
02/09/2000 |
K063536 |
TYCO HEALTHCARE GROUP |
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING |
01/29/2007 |
K072646 |
UNITED MEDICAL INDUSTRIES CO. LTD. |
UNICAPRONE |
11/07/2007 |
K042288 |
UNITED MEDICAL INDUSTRIES CO. LTD. |
UNICRYL |
12/27/2004 |
K072644 |
UNITED MEDICAL INDUSTRIES CO. LTD. |
UNICRYL QUICK |
11/07/2007 |
K072645 |
UNITED MEDICAL INDUSTRIES CO. LTD. |
UNIGLACTIN |
11/07/2007 |
K032586 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CAPROSYN ABSORBABLE SUTURE |
11/17/2003 |
K013671 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
L-25 ABSORBABLE SURIGCAL SUTURE |
01/08/2002 |
K990951 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE |
04/01/1999 |
K970863 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MODIFIED USSC* POLYSORB SUTURE |
05/05/1997 |
K000037 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MONOFILAMENT BIOSYN SUTURE |
03/30/2000 |
K981935 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
POLYSORB SUTURE |
06/25/1998 |
K963253 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SYNTHETIC ABSORBABLE SURGICAL SUTURE |
10/08/1996 |
K961997 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE |
07/16/1996 |
K102592 |
VISIONARY MEDICAL SUPPLIES, INC. |
SUTRAZORB |
02/03/2011 |
K073493 |
VYGON CORP. |
HEPATOSTAT SET |
05/06/2008 |
K061796 |
VYGON CORP. |
HEPATOSTAT SET, MODEL 760X |
11/02/2006 |