GAR · Class II · 21 CFR 878.5020

FDA Product Code GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Leading manufacturers include S. Jackson, Inc., United States Surgical, A Division of Tyco Healthc and Look, Inc..

57
Total
57
Cleared
171d
Avg days
1990
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 29d recently vs 173d historically

FDA 510(k) Cleared Suture, Nonabsorbable, Synthetic, Polyamide Devices (Product Code GAR)

57 devices
1–24 of 57
Cleared Jun 03, 2026
Tissue Approximation System
K261484
Tas Medical, Inc.
General & Plastic Surgery · 29d
Cleared Jul 05, 2023
Tissue Approximation System (TAS)
K220980
Tas Medical, Inc.
General & Plastic Surgery · 457d
Cleared Mar 31, 2022
Golnit Nylon Monofilament Suture
K212888
Antarma, LLC Dba Golnit Sutures
General & Plastic Surgery · 202d
Cleared Dec 22, 2021
Non Absorbable Surgical Nylon Suture
K212603
Shandong Haidike Medical Product Co., Ltd.
General & Plastic Surgery · 127d
Cleared May 29, 2020
Crownjun Nylon Suture
K192420
Kono Seisakusho Co., Ltd.
General & Plastic Surgery · 268d
Cleared Mar 02, 2017
REXLON, REXSIL
K161633
Sm Eng Co., Ltd.
General & Plastic Surgery · 262d
Cleared Feb 17, 2016
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165
Aesculap, Inc.
General & Plastic Surgery · 292d
Cleared Oct 28, 2015
RiverLon (Nylon) Suture
K152795
Riverpoint Medical
General & Plastic Surgery · 30d
Cleared May 28, 2013
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034
Unilene Sac
General & Plastic Surgery · 242d
Cleared Jul 15, 2008
KUMAR T-ANCHORS HERNIA SET
K081366
Nashville Surgical Instruments
General & Plastic Surgery · 61d
Cleared Jul 26, 2006
FSSB NYLON SURGICAL SUTURES
K060471
Fssb Chirurgische Nadeln GmbH
General & Plastic Surgery · 153d
Cleared May 19, 2006
MANI NEEDLE & SUTURE PACK (NYLON)
K053637
Mani, Inc.
General & Plastic Surgery · 141d
Cleared Mar 28, 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528
Aesculap, Inc.
General & Plastic Surgery · 28d
Cleared Nov 28, 2005
QUILL NONABSORBABLE NYLON BARBED SUTURE
K052900
Quill Medical, Inc.
General & Plastic Surgery · 45d
Cleared Oct 17, 2005
ARTELON SURGICAL SUTURE
K052482
Artimplant AB
General & Plastic Surgery · 38d
Cleared Jun 02, 2005
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
K041510
Sutures India Private Limited
General & Plastic Surgery · 360d
Cleared Dec 03, 2004
UNIMIDE
K042284
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 101d
Cleared Oct 14, 2004
NYLON THREADED NEEDLE
K042367
Aros Surgical Instruments Corp.
General & Plastic Surgery · 44d
Cleared Nov 17, 2003
ARTELON SURGICAL SUTURE
K032160
Artimplant AB
General & Plastic Surgery · 125d
Cleared Sep 23, 2003
S&T MICROSURGICAL SUTURE
K031531
S & T AG
General & Plastic Surgery · 131d
Cleared Jul 21, 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177
Sri Orion Pharmaceuticals & Sutures
General & Plastic Surgery · 185d
Cleared Jun 18, 2003
DEMETECH NYLON NONABSORBABLE SUTURE
K023028
Demetech Corp.
General & Plastic Surgery · 280d
Cleared Feb 28, 2003
NYLON SUTURE
K024090
Aurolab
General & Plastic Surgery · 79d
Cleared Apr 15, 2002
SERRALNYL
K020146
Serral, S.A. DE C.V.
General & Plastic Surgery · 89d

About Product Code GAR - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code GAR since 1990, with 57 receiving FDA clearance (average review time: 171 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - GAR Product Code

Recent submissions under GAR have taken an average of 29 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.

GAR devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →