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

Suture, Nonabsorbable, Synthetic, Polyethylene

Regulation 878.5000

5510(k)s in 12 months (176 all time)
0recalls in 12 months (23 all time)
21recalls that name a 510(k)
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Top companies in GAT

DateFirm and productCodeLinked 510(k)
Feb 25, 2023Covidien, LP
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Open, Classified
GATNone listed
Feb 25, 2023Covidien, LP
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0
Open, Classified
GATK990952
Feb 25, 2023Covidien, LP
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Open, Classified
GATK955747
Feb 25, 2023Covidien, LP
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5
Open, Classified
GATK990952
Aug 15, 2019Musculoskeletal Transplant Foundation, Inc.
QuickGraft Model # 430PST
Terminated
GATK181633
Feb 21, 2019ArthroCare Corporation
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Terminated
GATK123268
Jun 22, 2015Smith & Nephew, Inc.
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Terminated
GATK132079
Sep 22, 2014Peters Surgical
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolu
Terminated
GATK060163
Sep 22, 2014Peters Surgical
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with p
Terminated
GATK060163
May 7, 2014Teleflex Medical
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Terminated
GATK063778
K930738
May 7, 2014Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbabl
Terminated
GATK930738
Mar 26, 2014Teleflex Medical
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protei
Terminated
GATK021019
Mar 26, 2014Teleflex Medical
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consis
Terminated
GATK021019
Mar 26, 2014Teleflex Medical
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared
Terminated
GATK021019
Mar 26, 2014Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared
Terminated
GATK021019
Mar 26, 2014Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible
Terminated
GATK021019
Mar 26, 2014Teleflex Medical
Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphat
Terminated
GATK021019
Jan 11, 2012Innovatech Medical Resources L.P.
OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Terminated
GATK042031
Nov 18, 2010Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as sho
Terminated
GATK092508
Nov 18, 2010Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder st
Terminated
GATK092508
Nov 18, 2010Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder
Terminated
GATK092508
May 24, 2007C P Medical
Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with ins
Terminated
GATK001172
Jul 20, 2004Surgical Specialties Corp
Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)
Terminated
GATNone listed

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