Product Code: GAM
FDA class 2
21 CFR 878.4493
Suture, Absorbable, Synthetic, Polyglycolic Acid
General, Plastic Surgery
The Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM) is a synthetic absorbable suture made from polyglycolic acid, which is broken down by hydrolysis in the body over weeks to months, used for internal tissue closure during general and plastic surgery. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.4493 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed within body tissue during use.
510(k)s
143
FEI Numbers
148
Registration Numbers
148
Unique Applicants
67
Years Active
34
Basic Information
- Product Code
- GAM
- Device Class
- FDA class 2
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 143 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233265 | Monotime and Optime R | Oct 11, 2024 | Substantially Equivalent | Peters Surgical |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Jul 12, 2024 | Substantially Equivalent | Peters Surgical |
| K221527 | StitchKit | Feb 14, 2023 | Substantially Equivalent | Origami Surgical Inc . |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | Nov 15, 2022 | Substantially Equivalent | Ethicon, Inc. |
| K212810 | MONOFIX PGCL, knotless wound closure device | Aug 05, 2022 | Substantially Equivalent | Samyang Holdings Corp., Ltd. |
| K211792 | StitchKit | Jul 16, 2021 | Substantially Equivalent | Origami Surgical Inc . |
| K202950 | StitchKit COMBO | Feb 23, 2021 | Substantially Equivalent | Origami Surgical |
| K201996 | Monocryl Plus Antibacterial Suture | Dec 21, 2020 | Substantially Equivalent | Ethicon Inc. |
| K200392 | REXSIN | Jul 07, 2020 | Substantially Equivalent | SM ENG CO., LTD |
| K200140 | Silhouette Instalift | Mar 27, 2020 | Substantially Equivalent | Silhouette Lift Inc. |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | Dec 18, 2019 | Substantially Equivalent | Ethicon, Inc |
| K183183 | 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 | Jun 27, 2019 | Substantially Equivalent | Ethicon, Inc. |
| K183004 | WEGO-PGA RAPID | Jan 28, 2019 | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd |
| K183001 | WEGO-PGLA RAPID | Jan 28, 2019 | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | Sep 28, 2018 | Substantially Equivalent | Ethicon, Inc. |
| K181320 | Caprolon | Sep 18, 2018 | Substantially Equivalent | Resorba Medical GmbH |
| K180625 | Rondek PGA Suture (Beige or Violet) | May 10, 2018 | Substantially Equivalent | RK Manufacturing Corporation |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | May 04, 2018 | Substantially Equivalent | Origami Surgical LLC |
| K173779 | REXMONO, PDREX | Mar 12, 2018 | Substantially Equivalent | SM ENG CO., LTD |
| K173043 | Holycon Synthetic Absorbable Sutures | Dec 14, 2017 | Substantially Equivalent | Nantong Holycon Medical Devices Co., Ltd. |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | Oct 23, 2017 | Substantially Equivalent | Aesculap, Inc. |
| K170166 | CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture | Sep 29, 2017 | Substantially Equivalent | CPT Sutures Co., Ltd. |
| K172659 | 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(glycolide-co-caprolactone) Surgical Suture | Sep 28, 2017 | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited |
| K163676 | Silhouette InstaLift | Jun 16, 2017 | Substantially Equivalent | SILHOUETTE LIFT, INC. |
| K171494 | TroClose1200, TroClose1200 Cannula | Jun 15, 2017 | Substantially Equivalent | Gordian Surgical Ltd. |
| K170661 | Novosyn Quick Absorbable Suture | Jun 08, 2017 | Substantially Equivalent | Aesculap, Inc. |
| K161629 | CRYLREX | Feb 10, 2017 | Substantially Equivalent | SM ENG CO., LTD |
| K160564 | TroClose1200 | Nov 17, 2016 | Substantially Equivalent | GORDIAN SURGICAL LTD. |
| K161726 | E-Pack Procedure Kit | Jul 12, 2016 | Substantially Equivalent | ETHICON, INC. |
| K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device | Jun 03, 2016 | Substantially Equivalent | Ethicon, LLC |
| K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | Nov 02, 2015 | Substantially Equivalent | RESORBA MEDICAL GMBH |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron | Oct 14, 2015 | Substantially Equivalent | M/s. Meril Endo Surgery Private Limited |
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | Aug 13, 2015 | Substantially Equivalent | ETHICON, INC. |
| K142061 | SILHOUETTE INSTALIFT | Apr 24, 2015 | Substantially Equivalent | SILHOUETTE LIFT, INC. |
| K142822 | PLIASURE Polyglycolide Synthetic Absorbable Suture | Mar 26, 2015 | Substantially Equivalent | ETHICON, Inc. |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Nov 14, 2014 | Substantially Equivalent | FOOSIN MEDICAL SUPPLIES INC.LTD |
| K140039 | POLYCRYL | Sep 15, 2014 | Substantially Equivalent | AUROLAB |
| K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Jul 30, 2014 | Substantially Equivalent | SURGICAL SPECIALTIES CORPORATION |
| K141625 | POLYSYN SURGICAL SUTURE | Jul 18, 2014 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | Jul 11, 2014 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K123940 | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE | May 30, 2014 | Substantially Equivalent | DEMETECH CORP. |
| K140227 | MONODERM SURGICAL SUTURE | Feb 28, 2014 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | Feb 28, 2014 | Substantially Equivalent | ETHICON, INC. |
| K130737 | SYNTHETIC ABSORBABLE SUTURE | Jan 14, 2014 | Substantially Equivalent | FOOSIN MEDICAL SUPPLIES INC.LTD |
| K130735 | SYNTHETIC ABSORBABLE SUTURE | Jan 14, 2014 | Substantially Equivalent | FOOSIN MEDICAL SUPPLIES INC.LTD |
| K130083 | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE | Jul 17, 2013 | Substantially Equivalent | DEMETECH CORP. |
| K123836 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Dec 21, 2012 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
| K122734 | AESCULAP NOVOSYN ABSORBABLE SUTURE | Dec 18, 2012 | Substantially Equivalent | AESCULAP, INC. |
| K123409 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Nov 20, 2012 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
| K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Oct 22, 2012 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
| K120556 | VILET VILET QUICK | May 23, 2012 | Substantially Equivalent | RIVERPOINT MEDICAL |
| K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... | Jun 03, 2011 | Substantially Equivalent | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
| K102592 | SUTRAZORB | Feb 03, 2011 | Substantially Equivalent | VISIONARY MEDICAL SUPPLIES, INC. |
| K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | May 10, 2010 | Substantially Equivalent | SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
| K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Nov 12, 2009 | Substantially Equivalent | SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
| K091087 | MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Apr 22, 2009 | Substantially Equivalent | SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
| K082662 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Mar 26, 2009 | Substantially Equivalent | SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
| K080412 | ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) | Sep 04, 2008 | Substantially Equivalent | SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD. |
| K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE | Jun 09, 2008 | Substantially Equivalent | SUTURES INDIA PVT., LTD. |
| K081002 | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE | Jun 09, 2008 | Substantially Equivalent | SUTURES INDIA PVT., LTD. |
| K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES | May 23, 2008 | Substantially Equivalent | INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
| K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES | May 23, 2008 | Substantially Equivalent | INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
| K073493 | HEPATOSTAT SET | May 06, 2008 | Substantially Equivalent | VYGON CORP. |
| K072646 | UNICAPRONE | Nov 07, 2007 | Substantially Equivalent | UNITED MEDICAL INDUSTRIES CO. LTD. |
| K072645 | UNIGLACTIN | Nov 07, 2007 | Substantially Equivalent | UNITED MEDICAL INDUSTRIES CO. LTD. |
| K072644 | UNICRYL QUICK | Nov 07, 2007 | Substantially Equivalent | UNITED MEDICAL INDUSTRIES CO. LTD. |
| K072229 | MONOSWIFT | Oct 05, 2007 | Substantially Equivalent | CP MEDICAL |
| K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM | Aug 03, 2007 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K063536 | POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING | Jan 29, 2007 | Substantially Equivalent | TYCO HEALTHCARE GROUP |
| K063462 | NEATSTITCH NEATCLOSE SUTURING DEVICE | Jan 12, 2007 | Substantially Equivalent | NEAT STITCH LTD. |
| K061796 | HEPATOSTAT SET, MODEL 760X | Nov 02, 2006 | Substantially Equivalent | VYGON CORP. |
| K062366 | OPTIME, SINUSORB PGA | Oct 02, 2006 | Substantially Equivalent | PETERS SURGICAL |
| K060801 | DEKNA-LOK MODEL BP1000V2L | May 17, 2006 | Substantially Equivalent | TELEFLEX MEDICAL |
| K060828 | MODIFICATION TO ENDOTINE RIBBON | Apr 19, 2006 | Substantially Equivalent | COAPT SYSTEMS, INC. |
| K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) | Mar 14, 2006 | Substantially Equivalent | MANI, INC. |
| K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE | Nov 07, 2005 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K051700 | OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR | Aug 15, 2005 | Substantially Equivalent | MEDCHANNEL, LLC |
| K050845 | MONOCRYL PLUS ANTIBACTERIAL SUTURE | Jun 29, 2005 | Substantially Equivalent | ETHICON, INC. |
| K051415 | ENDOTINE RIBBON | Jun 23, 2005 | Substantially Equivalent | COAPT SYSTEMS, INC. |
| K050771 | LUPINE LOOP | Apr 08, 2005 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K041515 | TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE | Apr 08, 2005 | Substantially Equivalent | SUTURES INDIA PRIVATE LIMITED |
| K050611 | ENDOTINE RIBBON | Apr 06, 2005 | Substantially Equivalent | COAPT SYSTEMS, INC. |
| K043539 | DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES | Apr 06, 2005 | Substantially Equivalent | DEMETECH CORP. |
| K042288 | UNICRYL | Dec 27, 2004 | Substantially Equivalent | UNITED MEDICAL INDUSTRIES CO. LTD. |
| K042233 | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE | Sep 28, 2004 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K042141 | POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE | Sep 28, 2004 | Substantially Equivalent | TELEFLEX MEDICAL |
| K041806 | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP | Aug 03, 2004 | Substantially Equivalent | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K040477 | MONODERM | May 18, 2004 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K040282 | ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID | Apr 29, 2004 | Substantially Equivalent | INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
| K033762 | SERRALAPG | Mar 15, 2004 | Substantially Equivalent | SERRAL, S.A. DE C.V. |
| K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE | Dec 18, 2003 | Substantially Equivalent | ETHICON, INC. |
| K033115 | ORTHODEK | Nov 17, 2003 | Substantially Equivalent | TELEFLEX MEDICAL |
| K032586 | CAPROSYN ABSORBABLE SUTURE | Nov 17, 2003 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K032698 | COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE | Oct 23, 2003 | Substantially Equivalent | COAPT SYSTEMS, INC. |
| K032420 | MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | Oct 22, 2003 | Substantially Equivalent | ETHICON, INC. |
| K031286 | SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE | May 29, 2003 | Substantially Equivalent | AESCULAP, INC. |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent | CP MEDICAL |
| K022715 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE | Dec 19, 2002 | Substantially Equivalent | ETHICON, INC. |
| K021767 | ASSUFIL | Nov 19, 2002 | Substantially Equivalent | ASSUT EUROPE S.P.A. |
| K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | Sep 13, 2002 | Substantially Equivalent | ETHICON, INC. |
| K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. | Sep 10, 2002 | Substantially Equivalent | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
| K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED | Jan 28, 2002 | Substantially Equivalent | SURGICAL SPECIALTIES CORP. |
| K013671 | L-25 ABSORBABLE SURIGCAL SUTURE | Jan 08, 2002 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | Dec 19, 2001 | Substantially Equivalent | BONUTTI RESEARCH, INC. |
| K011372 | AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE | Aug 01, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K011375 | AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE | Jun 29, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K010672 | MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE | May 18, 2001 | Substantially Equivalent | GRAMSMED LLC |
| K002639 | BIOKNOTLESS ANCHOR | May 11, 2001 | Substantially Equivalent | MITEK PRODUCTS |
| K003017 | GRAMSORB SYNTHETIC ABSORBABLE SUTURE | Mar 13, 2001 | Substantially Equivalent | GRAMSMED LLC |
| K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) | Aug 10, 2000 | Substantially Equivalent for Some Indications | CP MEDICAL |
| K000037 | MONOFILAMENT BIOSYN SUTURE | Mar 30, 2000 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K994001 | POLYGLYCOLIC ACID | Feb 09, 2000 | Substantially Equivalent | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Sep 03, 1999 | Substantially Equivalent | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Jun 22, 1999 | Substantially Equivalent | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K984374 | SURGISORB | Jun 04, 1999 | Substantially Equivalent | SAMYANG CORP. |
| K990432 | SURGISORB | May 27, 1999 | Substantially Equivalent for Some Indications | SUTURES LTD. |
| K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE | Apr 01, 1999 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K981935 | POLYSORB SUTURE | Jun 25, 1998 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K980610 | DEXON RAPID (DEXON R) | May 18, 1998 | Substantially Equivalent | DAVIS & GECK, INC. |
| K980704 | SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE | May 11, 1998 | Substantially Equivalent | AESCULAP, INC. |
| K974299 | PANACRYL | Feb 13, 1998 | Substantially Equivalent | ETHICON, INC. |
| K972566 | DEXON VIOLET | Aug 14, 1997 | Substantially Equivalent | DAVIS & GECK, INC. |
| K971208 | MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS | May 13, 1997 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K970863 | MODIFIED USSC* POLYSORB SUTURE | May 05, 1997 | Substantially Equivalent for Some Indications | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K970317 | MODIFIED E-PACK PROCEDURE KIT | Apr 25, 1997 | Substantially Equivalent | ETHICON, INC. |
| K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. | Feb 12, 1997 | Substantially Equivalent | LUKENS MEDICAL CORP. |
| K964345 | ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED | Dec 16, 1996 | Substantially Equivalent | ETHICON, INC. |
| K963253 | SYNTHETIC ABSORBABLE SURGICAL SUTURE | Oct 08, 1996 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K962480 | COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED | Aug 02, 1996 | Substantially Equivalent | ETHICON, INC. |
| K961997 | USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE | Jul 16, 1996 | Substantially Equivalent for Some Indications | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K953869 | POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE | Oct 18, 1995 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K951520 | USSC POLYSORB SUTURE | Aug 21, 1995 | Substantially Equivalent for Some Indications | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K945285 | USSC MONOFILAMENT POLYSORB SUTURE | Aug 21, 1995 | Substantially Equivalent for Some Indications | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K946271 | VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT | Jun 15, 1995 | Substantially Equivalent | ETHICON, INC. |
| K951352 | DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE | Jun 05, 1995 | Substantially Equivalent | DAVIS & GECK, INC. |
| K944937 | SYNTHETIC ABSORBABLE SUTURE | May 19, 1995 | Substantially Equivalent | JOHNSON & JOHNSON INTERNATIONAL |
| K944110 | VICRYL RAPIDE SUTURE | Jan 18, 1995 | Substantially Equivalent for Some Indications | ETHICON, INC. |
| K930772 | ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE | Jan 07, 1994 | Substantially Equivalent | ETHICON, INC. |
| K930588 | DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID | Jan 07, 1994 | Substantially Equivalent | DAVIS & GECK, INC. |
| K930360 | SUTURES | Dec 17, 1993 | Substantially Equivalent | ETHICON, INC. |
| K930746 | SYNTHETIC ABSORBABLE SURGICAL SUTURE | Nov 17, 1993 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K915835 | COATED VICRYL* II | Mar 23, 1992 | Substantially Equivalent | ETHICON, INC. |
| K905482 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE | Mar 14, 1991 | Substantially Equivalent | PFIZER HOSPITAL PRODUCTS GROUP, INC. |
FEI Numbers
This FDA classification entry is associated with 148 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 148 registration numbers. Click on an entry to view related FDA registrations.