GAM

Product Code: GAM


Products Classified as GAM

5595Suture, Absorbable, Synthetic, Polyglycolic AcidAbsorbable Poly(glycolide/l-lactide) Surgical Suture.

Total Product Life Cycle (TPLC) Devices

5595Suture, Absorbable, Synthetic, Polyglycolic AcidAbsorbable Poly(glycolide/l-lactide) Surgical Suture.

FDA Consensus Standards

Suture, Absorbable, Synthetic, Polyglycolic Acid [38449]21 CFR §878.4493 🔎
Suture, Absorbable, Synthetic, Polyglycolic Acid [38450]21 CFR §878.4493 🔎
Suture, Absorbable, Synthetic, Polyglycolic Acid [38454]21 CFR §878.4493 🔎
Suture, Absorbable, Synthetic, Polyglycolic Acid [38451]21 CFR §878.4493 🔎

Pre-market Approvals for GAM

P840051MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SUDAVIS & GECK, INC.

Pre-market Notifications for GAM

K212810MONOFIX PGCL, Knotless Wound Closure DeviceSamyang Holdings Corp., Ltd.
K211792StitchKitOrigami Surgical Inc .
K200140Silhouette InstaliftSilhouette Lift Inc.
K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceEthicon, Inc
K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureEthicon, Inc.
K183004WEGO-PGA RAPIDFoosin Medical Supplies Inc., Ltd
K183001WEGO-PGLA RAPIDFoosin Medical Supplies Inc., Ltd
K181652Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureEthicon, Inc.
K181320CaprolonResorba Medical GmbH
K180625Rondek PGA Suture (Beige Or Violet)RK Manufacturing Corporation
K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical LLC
K173779REXMONO, PDREXSM ENG CO., LTD
K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd.
K172659MEGASORB - 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 PolM/s. Meril Endo Surgery Private Limited
K171494TroClose1200, TroClose1200 CannulaGordian Surgical Ltd.

Global Unique Device Identification Database

20386120007933Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007926Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007919Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007902Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007896Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007889Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007872Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007865Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007582Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007575Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007568Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007551Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007544Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007537Suture, Absorbable, Synthetic, Polyglycolic Acid
20386120007520Suture, Absorbable, Synthetic, Polyglycolic Acid

Maude Adverse Events

NOVOSYN VIOLET 1 (4) 90CM HR37S (M)B. BRAUN SURGICAL, S.A.2020-03-31
NOVOSYN VIOLET 0 (3.5) 90CM HR37S (M)B. BRAUN SURGICAL, S.A.2020-03-31
NOVOSYN VIOLET 1 (4) 90CM HR48 (M)B. BRAUN SURGICAL, S.A.2020-03-31
SAFIL VIOLET 0 (3.5) 90CM HR37S (M)B. BRAUN SURGICAL, S.A.2020-03-31
CAPROSYNDAVIS & GECK CARIBE LTD2020-03-31
SUTURE UNKNOWNETHICON INC.2020-03-31
VCL CT BRD VIO 36IN 0 S/A CT-1ETHICON INC.2020-03-31
CAPROSYNDAVIS & GECK CARIBE LTD2020-03-31
VCL+ VIO 36IN 0 S/A CTETHICON INC.2020-03-31
VICRYL VIO 70CM M2ETHICON INC.2020-03-31
VICRYL VIO 70CM M2ETHICON INC.2020-03-31
VICRYL RAP UND 75CM M1 USP5/0 SGLE ARMED C-3ETHICON INC.2020-03-30
VCL CT BRD UD 18IN 6-0 D/A S-22ETHICON INC.2020-03-30
V-LOC 180COVIDIEN LP LLC NORTH HAVEN2020-03-30
VCL+ VIO 27IN 2-0 S/A UR-6ETHICON INC.2020-03-30
VCL+ VIO 27IN 2-0 S/A UR-6ETHICON INC.2020-03-30
V-LOC 180COVIDIEN LP LLC NORTH HAVEN2020-03-30
V-LOC 180COVIDIEN LP LLC NORTH HAVEN2020-03-30
POLYSORBDAVIS & GECK CARIBE LTD2020-03-30
BIOSYNDAVIS & GECK CARIBE LTD2020-03-30
V-LOC 90COVIDIEN LP LLC NORTH HAVEN2020-03-30
VICRYL VIO 75CM M3ETHICON INC.2020-03-27
ABSORBABLE SURGICAL SUTUREETHICON INC.2020-03-27
MCRYL+ UD 18IN 5-0 S/A P-3 PRM MPETHICON INC.2020-03-27
MCRYL+ UD 18IN 5-0 S/A P-3 PRM MPETHICON INC.2020-03-27
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-27
MAXONDAVIS & GECK CARIBE LTD2020-03-27
POLYSORBCOVIDIEN LP LLC NORTH HAVEN2020-03-27
BIOSYNDAVIS & GECK CARIBE LTD2020-03-27
VICRYL ABS SUR SUT USP SYNETHICON INC.2020-03-27
BIOSYNCOVIDIEN LP LLC NORTH HAVEN2020-03-26
VCL CT BRD VIO 27IN 0 S/A CT-1ETHICON INC.2020-03-26
VCL+ UD 27IN 3-0 S/A FS-1ETHICON INC.2020-03-26
VCL+ UD 27IN 3-0 S/A FS-1ETHICON INC.2020-03-26
VCL+ UD 27IN 3-0 S/A FS-1ETHICON INC.2020-03-26
VICRYL POLYGLACTIN 910 SUTUREETHICON INC.2020-03-26
VICRYL POLYGLACTIN 910 SUTUREETHICON INC.2020-03-26
VICRYL POLYGLACTIN 910 SUTUREETHICON INC.2020-03-26
VICRYL POLYGLACTIN 910 SUTUREETHICON INC.2020-03-26
VCL CT BRD VIO 30IN 0 S/A V-5ETHICON INC.2020-03-26
STRATAFIX SUTURESURGICAL SPECIALTIES CORPORATION2020-03-26
SAFIL VIOLET 3/0 (2) 70CM HR22B. BRAUN SURGICAL, S.A.2020-03-26
VCL CT BRD UD 18IN 5-0 S/A P-1 PRIMEETHICON INC.2020-03-26
VCL CT BRD UD 18IN 5-0 S/A P-1 PRIMEETHICON INC.2020-03-26
MAXONDAVIS & GECK CARIBE LTD2020-03-26
MONOCRYL 4-0 ETHICON SUTURE NEEDLEETHICON, INC. / JOHNSON & JOHNSON2020-03-25
CAPROSYNDAVIS & GECK CARIBE LTD2020-03-25
MCRYL+ UD 18IN 5-0 S/A P-3 PRM MPETHICON INC.2020-03-25
VCL CT BRD UD 8X18IN 1 S/A CTB-1 CRETHICON INC.2020-03-25
MCRYL+ UD 18IN 5-0 S/A P-3 PRM MPETHICON INC.2020-03-25
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