Product code GAT— General, Plastic Surgery
HS Fiber
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 175
Adverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GAT
1–100 of 175- K261021 — EasyWhip Family
- K260775 — Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
- K254275 — HyperSuture All Green Extension Line
- K254188 — Meniscus Versaflex
- K253145 — Pre-Sutured Tendon
- K253024 — ProZip Knotless Implant
- K252225 — PowerKnot High Strength Sutures
- K252201 — HS Fiber
- K242201 — HyperSuture White/Green Extension Line
- K241376 — HyperSuture All Blue Extension Line
- K234079 — HyperSuture Extension Line
- K231163 — HS Fiber Sutures
- K230311 — HyperSuture
- K231183 — Non absorbable Surgical Polyester Suture
- K223500 — SuperBall Meniscal Repair System
- K223122 — MENIX®; MENIX® DUO
- K230510 — MyEllevate
- K213046 — AceConnex Pre-Sutured Fascia
- K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
- K223822 — ACTIVBRAID
- K220880 — Arthrex BioSuture
- K222078 — Arthrex SoftStitch
- K221354 — Arthrex SutureTape
- K220186 — Zone Specific AIM
- K220219 — PERMALOOP Suture, PERMATAPE Suture
- K212146 — Arthrex LoopLoc Knotless Suture
- K210675 — EasyWhip
- K203186 — DYNATAPE Suture
- K203393 — FAST-FIX FLEX
- K190707 — Arthrex SoftStitch
- K202242 — HS Fiber
- K193575 — Arthrex SutureTape
- K192490 — Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
- K192637 — High Strength Suture
- K190777 — DemeTECH DemeFORCE Nonabsorbable Surgical Suture
- K191268 — Force Fiber Suture
- K190817 — HS Fiber
- K181633 — MTF Pre-Sutured Tendon
- K181774 — Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
- K181182 — DYNACORD Suture
- K181772 — NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
- K180191 — SuperBall Meniscal Repair System
- K180531 — NovoStitch Pro Meniscal Repair System
- K170957 — ReConnex Pre-Sutured Tendon
- K172016 — Force Fiber Fusion Suture
- K170642 — GRAVITY Soft Tissue Repair System
- K171680 — Infinity-Lock 3, Infinity-Lock 5
- K171296 — SutureTape
- K163651 — ExpressBraid Graft Manipulation
- K163142 — SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
- K160854 — MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
- K162247 — PERMATAPE
- K162310 — XBraid TT Suture Tape
- K161638 — SPEEDTRAP Graft Preparation System
- K153089 — 'cottony' II TAPE, PLEDGETS
- K153087 — IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
- K153076 — silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
- K153746 — Dunamis Force DFX Tensile Tape
- K153307 — HS SutureTape
- K152868 — ExpressBraid Graft Manipulation
- K153096 — LARIAT RS Suture Delivery Device
- K151758 — ALAR Nasal Valve Stent
- K151009 — Nexus Suture
- K150584 — Stryker Suture Tape
- K143356 — NovoStitch Plus Meniscal Repair System
- K150327 — Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
- K150438 — Force Fiber OrthoTape suture
- K142241 — LARIAT sulture Delivery Device
- K141072 — SUPOLENE
- K133770 — A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
- K140019 — ARTHREX BIOSUTURE
- K132079 — TFCC FAST-FIX KIT
- K132357 — SMITH & NEPHEW ULTRATAPE
- K132043 — ARTHREX SPEEDCINCH
- K122735 — SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
- K123268 — SMARTSTITCH PERFECTPASSER SYSTEM
- K121861 — SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
- K122374 — ARTHREX SUTURE (UHMWPE)
- K121306 — SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
- K121413 — CROSSFIX II MEMISCAL REPAIR DEVICE
- K112899 — ARTHREX BIO-SUTURE
- K101377 — SMITH & NEWPHEW ULTRABRAID II SUTURE
- K102339 — CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
- K103052 — V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
- K102916 — G-CATH TISSUE ANCHOR DELIVERY CATHETER
- K102028 — NEOTRACT ANCHOR SYSTEM MODEL TAS400
- K101252 — NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
- K100006 — HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
- K094028 — CP-FIBER (ORTHOFIBER)
- K100572 — VERSACLOSE, MODEL VC-200-01
- K100506 — FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
- K100251 — G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
- K092508 — FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
- K091061 — IMPLICITGUIDE SURGICAL SUTURE SYSTEM
- K091574 — SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
- K093018 — G-PROX ENDOSCOPIC GRASPER, MODEL 205333
- K092533 — FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
- K091432 — XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
- K090385 — LARIAT II SUTURE DELIVERY DEVICE
- K091016 — COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.