ClearanceBrief
Panels › General, Plastic Surgery › Product code GAM · Class 2

Suture, Absorbable, Synthetic, Polyglycolic Acid

Regulation 878.4493

6510(k)s in 12 months (150 all time)
2recalls in 12 months (130 all time)
124recalls that name a 510(k)
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Top companies in GAM

Company510(k)sRecalls
ETHICON, Inc.2721
Riverpoint Medical241
Covidien LLC032
United States Surgical, A Division of Tyco Healthc120
Medtronic18
Surgical Specialties Corp81
Teleflex Creek Dr09
Aesculap, Inc.70
Mani, Inc. - Kiyohara Facility06
Cp Medical32
Decided510(k)Device and applicantCode
Sep 29, 2026K263073Fast Absorbing PGLA
Riverpoint Medical, LLC
GAM
Jun 25, 2026K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture
ETHICON, Inc.
GAM
May 28, 2026K253530Trexon™ Monofilament Synthetic Absorbable Suture
Medtronic
GAM
Feb 6, 2026K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
ETHICON, Inc.
GAM
Dec 22, 2025K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Dev
ETHICON, Inc.
GAM
Dec 16, 2025K253620TroClose 1200
Gordian Surgical, Ltd., IL
GAM
Oct 3, 2025K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Od
Internacional Farmacéutica S.A DE C.V, MX
GAM
Oct 11, 2024K233265Monotime and Optime R
Peters Surgical
GAM
Jul 12, 2024K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
Peters Surgical
GAM
Feb 14, 2023K221527StitchKit
Origami Surgical Inc .
GAM
Nov 15, 2022K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
ETHICON, Inc.
GAM
Aug 5, 2022K212810MONOFIX PGCL, knotless wound closure device
Samyang Holdings Corp., Ltd., KR
GAM
Jul 16, 2021K211792StitchKit
Origami Surgical Inc .
GAM
Feb 23, 2021K202950StitchKit COMBO
Origami Surgical
GAM
Dec 21, 2020K201996Monocryl Plus Antibacterial Suture
ETHICON, Inc.
GAM
Jul 7, 2020K200392REXSIN
Sm Eng Co., Ltd., KR
GAM
Mar 27, 2020K200140Silhouette Instalift
Silhouette Lift, Inc.
GAM
Dec 18, 2019K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
ETHICON, Inc.
GAM
Jun 27, 2019K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable S
ETHICON, Inc.
GAM
Jan 28, 2019K183004WEGO-PGA RAPID
Foosin Medical Supplies Inc., Ltd., CN
GAM
Jan 28, 2019K183001WEGO-PGLA RAPID
Foosin Medical Supplies Inc., Ltd., CN
GAM
Sep 28, 2018K181652Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
ETHICON, Inc.
GAM
Sep 18, 2018K181320Caprolon
Resorba Medical GmbH, DE
GAM
May 10, 2018K180625Rondek PGA Suture (Beige or Violet)
Rk Manufacturing Corporation
GAM
May 4, 2018K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
Origami Surgical, LLC
GAM
Mar 12, 2018K173779REXMONO, PDREX
Sm Eng Co., Ltd., KR
GAM
Dec 14, 2017K173043Holycon Synthetic Absorbable Sutures
Nantong Holycon Medical Devices Co., Ltd., CN
GAM
Oct 23, 2017K171001Monosyn Quick Synthetic Absorbable Surgical Suture
Aesculap, Inc.
GAM
Sep 29, 2017K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
Cpt Sutures Co., Ltd., VN
GAM
Sep 28, 2017K172659MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MI
M/s. Meril Endo Surgery Private Limited., IN
GAM
Jun 16, 2017K163676Silhouette InstaLift
Silhouette Lift, Inc.
GAM
Jun 15, 2017K171494TroClose1200, TroClose1200 Cannula
Gordian Surgical, Ltd., IL
GAM
Jun 8, 2017K170661Novosyn Quick Absorbable Suture
Aesculap, Inc.
GAM
Feb 10, 2017K161629CRYLREX
Sm Eng Co., Ltd., KR
GAM
Nov 17, 2016K160564TroClose1200
Gordian Surgical, Ltd., IL
GAM
Jul 12, 2016K161726E-Pack Procedure Kit
ETHICON, Inc.
GAM
Jun 3, 2016K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester
Ethicon, LLC
GAM
Nov 2, 2015K143584PGA RESORBA, PGA RESOQUICK, GLYCOLON
Resorba Medical GmbH, DE
GAM
Oct 14, 2015K150717Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
M/s. Meril Endo Surgery Private Limited., IN
GAM
Aug 13, 2015K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
ETHICON, Inc.
GAM
Apr 24, 2015K142061SILHOUETTE INSTALIFT
Silhouette Lift, Inc.
GAM
Mar 26, 2015K142822PLIASURE Polyglycolide Synthetic Absorbable Suture
ETHICON, Inc.
GAM
Nov 14, 2014K142810WEGO-PGCL Absorbable Surgical Monofilament Suture
Foosin Medical Supplies Inc., Ltd., CN
GAM
Sep 15, 2014K140039POLYCRYL
Aurolab, IN
GAM
Jul 30, 2014K141778QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Surgical Specialties Corporation
GAM
Jul 18, 2014K141625POLYSYN SURGICAL SUTURE
Surgical Specialties Corp
GAM
Jul 11, 2014K141558QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
Surgical Specialties Corp
GAM
May 30, 2014K123940DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
Demetech Corp.
GAM
Feb 28, 2014K140227MONODERM SURGICAL SUTURE
Surgical Specialties Corp
GAM
Feb 28, 2014K132580COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
ETHICON, Inc.
GAM

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