GAR · Class II · 21 CFR 878.5020

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

Leading manufacturers include Aesculap, Inc., United States Surgical, A Division of Tyco Healthc and Tas Medical, 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 Feb 17, 2016
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165
Aesculap, Inc.
General & Plastic Surgery · 292d
Cleared Mar 28, 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528
Aesculap, Inc.
General & Plastic Surgery · 28d
Cleared Mar 22, 1999
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared Jan 29, 1991
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 90d
Cleared Jan 17, 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 48d
Cleared Jul 05, 1990
NONABSORBABLE NYLON SURGICAL SUTURE*
K900531
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 150d

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 →