GAQ · Class II · 21 CFR 878.4495

FDA Product Code GAQ: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Leading manufacturers include Ethicon, Inc., Synthes (Usa) and Aesculap, Inc..

32
Total
32
Cleared
166d
Avg days
1987
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Devices (Product Code GAQ)

32 devices
1–24 of 32
Cleared Apr 22, 2022
CoNextions TR Tendon Repair System
K203855
Conextions Medical
General & Plastic Surgery · 477d
Cleared Feb 19, 2020
Wego-Stainless Steel
K193209
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 01, 2018
MERISTEEL
K172146
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 199d
Cleared Nov 01, 2017
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767
Ethicon, Inc.
General & Plastic Surgery · 232d
Cleared May 27, 2005
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606
Synthes (Usa)
General & Plastic Surgery · 245d
Cleared Aug 27, 2004
SYNTHES (USA) TITANIUM WIRE
K041333
Synthes (Usa)
General & Plastic Surgery · 100d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411
Aesculap, Inc.
General & Plastic Surgery · 69d
Cleared Jan 09, 1995
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
K946173
Ethicon, Inc.
General & Plastic Surgery · 21d
Cleared Jan 07, 1994
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE
K931271
Ethicon, Inc.
General & Plastic Surgery · 305d
Cleared Nov 17, 1987
STAINLESS 22-13-5 SUTURE WIRE
K873645
Zimmer, Inc.
General & Plastic Surgery · 70d

About Product Code GAQ - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code GAQ since 1987, with 32 receiving FDA clearance (average review time: 166 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.