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GAR — Suture, Nonabsorbable, Synthetic, Polyamide Class II

FDA Device Classification

Classification Details

Product Code
GAR
Device Class
Class II
Regulation Number
878.5020
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220980tas medicalTissue Approximation System (TAS)July 5, 2023
K212888antarma, llc dba golnit suturesGolnit Nylon Monofilament SutureMarch 31, 2022
K212603shandong haidike medical product coNon Absorbable Surgical Nylon SutureDecember 22, 2021
K192420kono seisakusho coCrownjun Nylon SutureMay 29, 2020
K161633sm eng coREXLON, REXSILMarch 2, 2017
K151165aesculapAesculap Dafilon Nonabsorbable Polyamide Surgical SutureFebruary 17, 2016
K152795riverpoint medicalRiverLon (Nylon) SutureOctober 28, 2015
K123034unilene sacVITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMEDMay 28, 2013
K081366nashville surgical instrumentsKUMAR T-ANCHORS HERNIA SETJuly 15, 2008
K060471fssb chirurgische nadelnFSSB NYLON SURGICAL SUTURESJuly 26, 2006
K053637maniMANI NEEDLE & SUTURE PACK (NYLON)May 19, 2006
K060528aesculapAESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTUREMarch 28, 2006
K052900quill medicalQUILL NONABSORBABLE NYLON BARBED SUTURENovember 28, 2005
K052482artimplantARTELON SURGICAL SUTUREOctober 17, 2005
K041510sutures india private limitedTRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTUREJune 2, 2005
K042284united medical industries co.UNIMIDEDecember 3, 2004
K042367aros surgical instrumentsNYLON THREADED NEEDLEOctober 14, 2004
K032160artimplantARTELON SURGICAL SUTURENovember 17, 2003
K031531s and tS&T MICROSURGICAL SUTURESeptember 23, 2003
K030177sri orion pharmaceuticals and suturesORLON NONABSORABLE SURGICAL SUTURE USPJuly 21, 2003