Product Code: GAW


Products Classified as GAW

5603Suture, Nonabsorbable, Synthetic, PolypropyleneNonabsorbable Polypropylene Surgical Suture.

Total Product Life Cycle (TPLC) Devices

5603Suture, Nonabsorbable, Synthetic, PolypropyleneNonabsorbable Polypropylene Surgical Suture.

FDA Consensus Standards

Suture, Nonabsorbable, Synthetic, Polypropylene [38209]21 CFR §878.5010 🔎
Suture, Nonabsorbable, Synthetic, Polypropylene [38449]21 CFR §878.5010 🔎
Suture, Nonabsorbable, Synthetic, Polypropylene [38450]21 CFR §878.5010 🔎
Suture, Nonabsorbable, Synthetic, Polypropylene [38448]21 CFR §878.5010 🔎
Suture, Nonabsorbable, Synthetic, Polypropylene [38451]21 CFR §878.5010 🔎

Pre-market Approvals for GAW

P890002POLYPROPYLENE SURGICAL SUTUREALCON LABORATORIES

Pre-market Notifications for GAW

K193530Deklene MAXXTeleflex Medical
K191299Silhouette Featherlift / Silhouette LiftSilhouette Lift Inc.
K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc.
K173747REXLENESM ENG CO., LTD
K173644Gazelle Polypropylene Suture And Delivery DeviceDura Tap LLC
K171039Assut Filbloc Permanent SuturesAssut Europe S.p.A.
K171005Silhouette FeatherliftSilhouette Lift Inc.
K162617NobleStitch ELNOBLES MEDICAL TECHNOLOGIES II, INC.
K160529Pledgeted COR-SUTURE QUICK LOADLSI SOULTIONS
K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignANGIOTECH
K143582MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEELRESORBA MEDICAL GMBH
K142639StitchKitORIGAMI SURGICAL LLC
K141206EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEMEDWARDS LIFESCIENCES LLC.
K133890AESCULAP OPTILENE NONABSORBABLE SUTUREAESCULAP, INC.
K133356PROLENE POLYPROPYLENE NONABSORBABLE SUTUREETHICON, INC.

Global Unique Device Identification Database

20386120007841Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007834Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007827Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007810Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007803Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007797Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007780Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007773Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007766Suture, Nonabsorbable, Synthetic, Polypropylene
20386120007759Suture, Nonabsorbable, Synthetic, Polypropylene
20386120006264Suture, Nonabsorbable, Synthetic, Polypropylene
20386120006257Suture, Nonabsorbable, Synthetic, Polypropylene
20386120006240Suture, Nonabsorbable, Synthetic, Polypropylene
20386120006233Suture, Nonabsorbable, Synthetic, Polypropylene
20386120006226Suture, Nonabsorbable, Synthetic, Polypropylene

Maude Adverse Events

PROLENE BLU 45CM M1.5ETHICON INC.2020-03-31
PROLENE*BLUE 3-0 45CM (1)SC-24ETHICON INC.2020-03-31
PRLNE BLU 24IN 7-0 D/A BV175-6 MPETHICON INC.2020-03-31
PROLENE BLU 75CM M1.5ETHICON INC.2020-03-31
PROLENE BLU 75CM M1.5ETHICON INC.2020-03-31
PROLENE SUT 30IN(75CM) 6-0 BLUETHICON INC.2020-03-31
PROLENE SUT 30IN(75CM) 6-0 BLUETHICON INC.2020-03-31
PROLENE SUT 30IN(75CM) 6-0 BLUETHICON INC.2020-03-31
NON ABSORBABLE SURGICAL SUTUREETHICON INC.2020-03-31
NON ABSORBABLE SURGICAL SUTUREETHICON INC.2020-03-31
SURGIPRODAVIS & GECK CARIBE LTD2020-03-30
SURGIPRODAVIS & GECK CARIBE LTD2020-03-30
SURGIPRO LLDAVIS & GECK CARIBE LTD2020-03-30
SURGIPRO IIDAVIS & GECK CARIBE LTD2020-03-29
SURGIPRO IIDAVIS & GECK CARIBE LTD2020-03-29
SURGIPRO IIDAVIS & GECK CARIBE LTD2020-03-29
PROLENE BLUE 1.0M 90CM W/NDLETHICON INC.2020-03-27
PROLENE BLUE 1.0M 90CM W/NDLETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PROLENE*BLUE3-0 45CM(1)PS-1 PRETHICON INC.2020-03-27
PRLNE BLU 4X30IN 7-0 D/A BV175-6 EPETHICON INC.2020-03-26
PRLNE BLU 4X30IN 7-0 D/A BV175-6 EPETHICON INC.2020-03-26
PRLNE BLU 4X30IN 7-0 D/A BV175-6 EPETHICON INC.2020-03-26
PRLNE BLU 4X30IN 7-0 D/A BV175-6 EPETHICON INC.2020-03-26
PROLENE SUTURE 36"(90CM) 4-0 BLUETHICON INC.2020-03-25
PROLENE SUTURE 36"(90CM) 4-0 BLUETHICON INC.2020-03-25
PROLENE SUTURE 36"(90CM) 4-0 BLUETHICON INC.2020-03-25
3-0 PROLENE BLUE SUTURE CC-30ETHICON INC.2020-03-25
PROLENE SUTURE 30"(75CM) 5-0 BLUETHICON INC.2020-03-25
PROLENE SUTURE 30"(75CM) 2-0 BLUETHICON INC.2020-03-25
UNKNOWNW.L. GORE & ASSOCIATES2020-03-25
PRLNE BLU 4X30IN 7-0 D/A BV-1ETHICON INC.2020-03-25
PRLNE BLU 4X30IN 7-0 D/A BV-1ETHICON INC.2020-03-25
PRLNE BLU 4X30IN 7-0 D/A BV-1ETHICON INC.2020-03-25
PROLENE SUT 24IN(60CM) 6-0 BLUETHICON INC.2020-03-25
PROLENE SUT 24IN(60CM) 6-0 BLUETHICON INC.2020-03-25
SURGIPRODAVIS & GECK CARIBE LTD2020-03-25
PRLNE BLU 24IN 7-0 D/A BV175-8 EPETHICON INC.2020-03-24
SURGIPRO LLDAVIS & GECK CARIBE LTD2020-03-24
SURGIPRO LLDAVIS & GECK CARIBE LTD2020-03-24
SURGIPRODAVIS & GECK CARIBE LTD2020-03-24
SURGIPRO LLDAVIS & GECK CARIBE LTD2020-03-24
SURGIPRO IIDAVIS & GECK CARIBE LTD2020-03-24
PROLENE SUT 24IN(60CM) 7-0 BLUETHICON INC.2020-03-24

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