GAQ · Class II · 21 CFR 878.4495

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

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

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 Sep 25, 2014
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007
Demetech Corp.
General & Plastic Surgery · 160d
Cleared May 28, 2014
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
K140127
Pontis Orthopaedics, LLC
General & Plastic Surgery · 132d
Cleared Dec 24, 2008
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
K081060
Core Essence Orthopaedics, LLC
General & Plastic Surgery · 254d
Cleared Oct 14, 2008
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
K082828
Suturtek Incorporated
General & Plastic Surgery · 19d
Cleared Feb 07, 2007
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
K063603
Suturtek Incorporated
General & Plastic Surgery · 66d
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 Sep 23, 2003
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468
Suturtek Incorporated
General & Plastic Surgery · 43d
Cleared May 15, 2003
TENO FIX
K023594
Ortheon Medical, LLC
General & Plastic Surgery · 202d
Cleared Mar 28, 2003
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351
Cp Medical
General & Plastic Surgery · 53d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411
Aesculap, Inc.
General & Plastic Surgery · 69d
Cleared Nov 19, 2002
MANUAL TOUCHE SYSTEM
K022777
Onux Medical, Inc.
General & Plastic Surgery · 90d
Cleared Oct 22, 2001
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
K013059
Stony Brook Surgical Innovations, Inc.
General & Plastic Surgery · 41d
Cleared Jul 30, 1999
ACIER SUTURES
K991073
Cardio Thoracic Systems
General & Plastic Surgery · 121d
Cleared Apr 28, 1999
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
K984151
Mill Pond, Inc.
General & Plastic Surgery · 160d
Cleared Feb 27, 1996
STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)
K955723
Davis & Geck, Inc.
General & Plastic Surgery · 71d
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 Jul 26, 1994
SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
K930740
Deknatel, Inc.
General & Plastic Surgery · 529d
Cleared Mar 03, 1994
STAINLESS STEEL SUTURE
K931915
Surgimetrics International, Ltd.
General & Plastic Surgery · 321d
Cleared Jan 07, 1994
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE
K931271
Ethicon, Inc.
General & Plastic Surgery · 305d

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.