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)
Top companies in GAT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2023 | Covidien, LP Custom Suture Pack
Product Description:
US1638 CUSTOM SUTURE PACK
US1756 CUSTOM SUTURE PACK Open, Classified |
GAT | None listed |
| Feb 25, 2023 | Covidien, 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 |
GAT | K990952 |
| Feb 25, 2023 | Covidien, LP Surgidac Uncoated Braided Polyester suture Product Description
D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA Open, Classified |
GAT | K955747 |
| Feb 25, 2023 | Covidien, 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 |
GAT | K990952 |
| Aug 15, 2019 | Musculoskeletal Transplant Foundation, Inc. QuickGraft
Model # 430PST Terminated |
GAT | K181633 |
| Feb 21, 2019 | ArthroCare Corporation Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971 Terminated |
GAT | K123268 |
| Jun 22, 2015 | Smith & Nephew, Inc. ULTRA-FAST FIX Knot Pusher Suture Cutters
Product Number: 72201537
Intended for Meniscal Repair. Terminated |
GAT | K132079 |
| Sep 22, 2014 | Peters 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 |
GAT | K060163 |
| Sep 22, 2014 | Peters 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 |
GAT | K060163 |
| May 7, 2014 | Teleflex 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 |
GAT | K063778 K930738 |
| May 7, 2014 | Teleflex 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 |
GAT | K930738 |
| Mar 26, 2014 | Teleflex 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 |
GAT | K021019 |
| Mar 26, 2014 | Teleflex 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 |
GAT | K021019 |
| Mar 26, 2014 | Teleflex 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 |
GAT | K021019 |
| Mar 26, 2014 | Teleflex 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 |
GAT | K021019 |
| Mar 26, 2014 | Teleflex 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 |
GAT | K021019 |
| Mar 26, 2014 | Teleflex 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 |
GAT | K021019 |
| Jan 11, 2012 | Innovatech 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 |
GAT | K042031 |
| Nov 18, 2010 | Smith & 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 |
GAT | K092508 |
| Nov 18, 2010 | Smith & 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 |
GAT | K092508 |
| Nov 18, 2010 | Smith & 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 |
GAT | K092508 |
| May 24, 2007 | C 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 |
GAT | K001172 |
| Jul 20, 2004 | Surgical 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 |
GAT | None listed |
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