FDA 510(k) Applications for Medical Device Product Code "GAM"
(Suture, Absorbable, Synthetic, Polyglycolic Acid)

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
K930588 DAVIS & GECK, INC. DEXON "S", DEXON PLUS, AND DEXON II POLYCOLIC ACID 01/07/1994
K980610 DAVIS & GECK, INC. DEXON RAPID (DEXON R) 05/18/1998
K951352 DAVIS & GECK, INC. DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE 06/05/1995
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
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
K915835 ETHICON, INC. COATED VICRYL* II 03/23/1992
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
K930772 ETHICON, INC. ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE 01/07/1994
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
K930360 ETHICON, INC. SUTURES 12/17/1993
K944110 ETHICON, INC. VICRYL RAPIDE SUTURE 01/18/1995
K946271 ETHICON, INC. VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT 06/15/1995
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
K944937 JOHNSON & JOHNSON INTERNATIONAL SYNTHETIC ABSORBABLE SUTURE 05/19/1995
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
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
K905482 PFIZER HOSPITAL PRODUCTS GROUP, INC. BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE 03/14/1991
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
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
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
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
K953869 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE 10/18/1995
K981935 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC POLYSORB SUTURE 06/25/1998
K930746 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SYNTHETIC ABSORBABLE SURGICAL SUTURE 11/17/1993
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
K945285 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC USSC MONOFILAMENT POLYSORB SUTURE 08/21/1995
K951520 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC USSC POLYSORB SUTURE 08/21/1995
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


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