Atlas FDA

GAM

149 FDA 510(k) clearances · Product code

86 daysmedian time to decision
268 days90th percentile
149clearances measured

FDA profile

Official device name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4493
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 4,506 · 2022: 4,814 · 2023: 5,070 · 2024: 7,226 · 2025: 9,119 · 2026: 5,324
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (K253394)ETHICON, Inc.2026-06-25
Trexon™ Monofilament Synthetic Absorbable Suture (K253530)Medtronic2026-05-28
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (K253852)ETHICON, Inc.2026-02-06
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K252743)ETHICON, Inc.2025-12-22
TroClose 1200 (K253620)Gordian Surgical, Ltd.2025-12-16
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (K252820)Internacional Farmacéutica S.A DE C.V2025-10-03
Monotime and Optime R (K233265)Peters Surgical2024-10-11
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372)Peters Surgical2024-07-12
StitchKit (K221527)Origami Surgical Inc .2023-02-14
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K221744)ETHICON, Inc.2022-11-15
MONOFIX PGCL, knotless wound closure device (K212810)Samyang Holdings Corp., Ltd.2022-08-05
StitchKit (K211792)Origami Surgical Inc .2021-07-16
StitchKit COMBO (K202950)Origami Surgical2021-02-23
Monocryl Plus Antibacterial Suture (K201996)ETHICON, Inc.2020-12-21
REXSIN (K200392)Sm Eng Co., Ltd.2020-07-07
Silhouette Instalift (K200140)Silhouette Lift, Inc.2020-03-27
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device (K192580)ETHICON, Inc.2019-12-18
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 (K183183)ETHICON, Inc.2019-06-27
WEGO-PGLA RAPID (K183001)Foosin Medical Supplies Inc., Ltd.2019-01-28
WEGO-PGA RAPID (K183004)Foosin Medical Supplies Inc., Ltd.2019-01-28
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture (K181652)ETHICON, Inc.2018-09-28
Caprolon (K181320)Resorba Medical GmbH2018-09-18
Rondek PGA Suture (Beige or Violet) (K180625)Rk Manufacturing Corporation2018-05-10
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO (K173874)Origami Surgical, LLC2018-05-04
REXMONO, PDREX (K173779)Sm Eng Co., Ltd.2018-03-12
Holycon Synthetic Absorbable Sutures (K173043)Nantong Holycon Medical Devices Co., Ltd.2017-12-14
Monosyn Quick Synthetic Absorbable Surgical Suture (K171001)Aesculap, Inc.2017-10-23
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture (K170166)Cpt Sutures Co., Ltd.2017-09-29
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 (K172659)M/s. Meril Endo Surgery Private Limited.2017-09-28
Silhouette InstaLift (K163676)Silhouette Lift, Inc.2017-06-16
TroClose1200, TroClose1200 Cannula (K171494)Gordian Surgical, Ltd.2017-06-15
Novosyn Quick Absorbable Suture (K170661)Aesculap, Inc.2017-06-08
CRYLREX (K161629)Sm Eng Co., Ltd.2017-02-10
TroClose1200 (K160564)Gordian Surgical, Ltd.2016-11-17
E-Pack Procedure Kit (K161726)ETHICON, Inc.2016-07-12
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device (K153611)Ethicon, LLC2016-06-03
PGA RESORBA, PGA RESOQUICK, GLYCOLON (K143584)Resorba Medical GmbH2015-11-02
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron (K150717)M/s. Meril Endo Surgery Private Limited.2015-10-14
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (K151200)ETHICON, Inc.2015-08-13
SILHOUETTE INSTALIFT (K142061)Silhouette Lift, Inc.2015-04-24
PLIASURE Polyglycolide Synthetic Absorbable Suture (K142822)ETHICON, Inc.2015-03-26
WEGO-PGCL Absorbable Surgical Monofilament Suture (K142810)Foosin Medical Supplies Inc., Ltd.2014-11-14
POLYCRYL (K140039)Aurolab2014-09-15
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K141778)Surgical Specialties Corporation2014-07-30
POLYSYN SURGICAL SUTURE (K141625)Surgical Specialties Corp2014-07-18
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE (K141558)Surgical Specialties Corp2014-07-11
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE (K123940)Demetech Corp.2014-05-30
MONODERM SURGICAL SUTURE (K140227)Surgical Specialties Corp2014-02-28
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE (K132580)ETHICON, Inc.2014-02-28
SYNTHETIC ABSORBABLE SUTURE (K130737)Foosin Medical Supplies Inc., Ltd.2014-01-14
SYNTHETIC ABSORBABLE SUTURE (K130735)Foosin Medical Supplies Inc., Ltd.2014-01-14
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE (K130083)Demetech Corp.2013-07-17
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K123836)Surgical Specialties Corp. Dba Angiotech2012-12-21
AESCULAP NOVOSYN ABSORBABLE SUTURE (K122734)Aesculap, Inc.2012-12-18
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K123409)Surgical Specialties Corp. Dba Angiotech2012-11-20
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K122898)Surgical Specialties Corp. Dba Angiotech2012-10-22
VILET VILET QUICK (K120556)Riverpoint Medical2012-05-23
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... (K111442)Covidien, Formerly US Surgical A Divison of Tyco H2011-06-03
SUTRAZORB (K102592)Visionary Medical Supplies, Inc.2011-02-03
VLOC9ABSORBABLE WOUND CLOSURE DEVICE (K100257)Surgical Devices, A Division of Tyco Healthcare2010-05-10
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K093408)Surgical Devices, A Division of Tyco Healthcare2009-11-12
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K091087)Surgical Devices, Tyco Healthcare Group LP2009-04-22
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K082662)Surgical Devices, Tyco Healthcare Group LP2009-03-26
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) (K080412)Shanghai Pudong Jinhuan Medical Products Co., Ltd.2008-09-04
TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE (K081003)Sutures India Pvt., Ltd.2008-06-09
MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE (K081002)Sutures India Pvt., Ltd.2008-06-09
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES (K072859)Internacional Farmaceutica, S.A. DE C.V.2008-05-23
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES (K072863)Internacional Farmaceutica, S.A. DE C.V.2008-05-23
HEPATOSTAT SET (K073493)Vygon Corp.2008-05-06
UNICAPRONE (K072646)United Medical Industries Co. , Ltd.2007-11-07
UNIGLACTIN (K072645)United Medical Industries Co. , Ltd.2007-11-07
UNICRYL QUICK (K072644)United Medical Industries Co. , Ltd.2007-11-07
MONOSWIFT (K072229)Cp Medical2007-10-05
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM (K072028)Surgical Specialties Corp2007-08-03
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING (K063536)Tyco Healthcare Group2007-01-29
NEATSTITCH NEATCLOSE SUTURING DEVICE (K063462)Neat Stitch , Ltd.2007-01-12
HEPATOSTAT SET, MODEL 760X (K061796)Vygon Corp.2006-11-02
OPTIME, SINUSORB PGA (K062366)Peters Surgical2006-10-02
DEKNA-LOK MODEL BP1000V2L (K060801)Teleflex Medical2006-05-17
MODIFICATION TO ENDOTINE RIBBON (K060828)Coapt Systems, Inc.2006-04-19
MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) (K053636)Mani, Inc.2006-03-14
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE (K052437)Surgical Specialties Corp2005-11-07
OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR (K051700)Medchannel, LLC2005-08-15
MONOCRYL PLUS ANTIBACTERIAL SUTURE (K050845)ETHICON, Inc.2005-06-29
ENDOTINE RIBBON (K051415)Coapt Systems, Inc.2005-06-23
LUPINE LOOP (K050771)Depuy Mitek, A Johnson & Johnson Company2005-04-08
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE (K041515)Sutures India Private Limited2005-04-08
ENDOTINE RIBBON (K050611)Coapt Systems, Inc.2005-04-06
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (K043539)Demetech Corp.2005-04-06
UNICRYL (K042288)United Medical Industries Co. , Ltd.2004-12-27
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE (K042233)Depuy Mitek, A Johnson & Johnson Company2004-09-28
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE (K042141)Teleflex Medical2004-09-28
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP (K041806)Depuy Mitek, A Johnson & Johnson Company2004-08-03
MONODERM (K040477)Surgical Specialties Corp2004-05-18
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID (K040282)Internacional Farmaceutica, S.A. DE C.V.2004-04-29
SERRALAPG (K033762)Serral, S.A. DE C.V.2004-03-15
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE (K033746)ETHICON, Inc.2003-12-18
ORTHODEK (K033115)Teleflex Medical2003-11-17
CAPROSYN ABSORBABLE SUTURE (K032586)United States Surgical, A Division of Tyco Healthc2003-11-17
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE (K032698)Coapt Systems, Inc.2003-10-23
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Every clearance here is in the API, with alerts when new ones post.