GAW · Class II · 21 CFR 878.5010

FDA Product Code GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Leading manufacturers include Ethicon, Inc., United States Surgical, A Division of Tyco Healthc and Aesculap, Inc..

85
Total
85
Cleared
125d
Avg days
1990
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 130d avg (recent)

FDA 510(k) Cleared Suture, Nonabsorbable, Synthetic, Polypropylene Devices (Product Code GAW)

85 devices
1–24 of 85
Cleared Mar 27, 2026
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device
K253572
Ethicon, Inc.
General & Plastic Surgery · 130d
Cleared Jan 12, 2024
Cypris eXact Suturing System
K233355
Cypris Medical
General & Plastic Surgery · 105d
Cleared Sep 14, 2023
Non absorbable Surgical Polypropylene Suture
K230746
Shandong Haidike Medical Products Co., Ltd.
General & Plastic Surgery · 181d
Cleared Dec 09, 2022
Vesseal
K221280
Lydus Medical , Ltd.
General & Plastic Surgery · 220d
Cleared Sep 02, 2022
DURAMESH Mesh Suture
K211178
Msi
General & Plastic Surgery · 500d
Cleared Aug 27, 2020
APTOS Threads – Polypropylene Surgical Sutures
K192953
Aptos, LLC
General & Plastic Surgery · 311d
Cleared Mar 19, 2020
Deklene MAXX
K193530
Teleflex Medical
General & Plastic Surgery · 90d
Cleared Jun 14, 2019
Silhouette Featherlift / Silhouette Lift
K191299
Silhouette Lift, Inc.
General & Plastic Surgery · 31d
Cleared Dec 21, 2018
REXLENE
K173747
Sm Eng Co., Ltd.
General & Plastic Surgery · 378d
Cleared Mar 07, 2018
Aesculap Optilene Nonabsorbable Suture
K180321
Aesculap, Inc.
General & Plastic Surgery · 30d
Cleared Feb 15, 2018
Gazelle Polypropylene Suture and Delivery Device
K173644
Dura Tap, LLC
General & Plastic Surgery · 80d
Cleared Jul 15, 2014
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890
Aesculap, Inc.
General & Plastic Surgery · 207d
Cleared Dec 06, 2013
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 47d
Cleared Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared May 04, 1998
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared May 16, 1996
VIEWPOINT
K961168
Philips Medical Systems (Cleveland), Inc.
General & Plastic Surgery · 52d
Cleared Feb 27, 1996
USSC POLYPROPLENE SUTURE
K954808
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 131d
Cleared Jul 30, 1992
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437
Ethicon, Inc.
General & Plastic Surgery · 178d
Cleared Sep 27, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 90d

About Product Code GAW - Regulatory Context

510(k) Submission Activity

85 total 510(k) submissions under product code GAW since 1990, with 85 receiving FDA clearance (average review time: 125 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - GAW Product Code

FDA review times for GAW submissions have been consistent, averaging 130 days recently vs 125 days historically.

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