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 |
| 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 |
| K233265 | Peters Surgical | Monotime and Optime R | 10/11/2024 |
| K062366 | PETERS SURGICAL | OPTIME, SINUSORB PGA | 10/02/2006 |
| K232372 | Peters Surgical | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | 07/12/2024 |
| 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 |
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