Product Code: GAQ FDA class 2 21 CFR 878.4495

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

General, Plastic Surgery

The Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ) is a sterile stainless steel suture available in both monofilament and multifilament configurations, used in general and plastic surgery for applications requiring high tensile strength and long-term tissue support. It is classified as FDA Class 2, which requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.4495 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed within or through body tissue.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GAQ
Device Class: FDA class 2
Regulation Number: 878.4495
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203855	CoNextions TR Tendon Repair System	Apr 22, 2022	Substantially Equivalent	Conextions Medical
K193209	Wego-Stainless Steel	Feb 19, 2020	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.
K172146	MERISTEEL	Feb 01, 2018	Substantially Equivalent	M/s. Meril Endo Surgery Private Limited.
K170767	Surgical Stainless Steel Suture, Stainless Steel Suture	Nov 01, 2017	Substantially Equivalent	ETHICON, Inc.
K141007	DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE	Sep 25, 2014	Substantially Equivalent	Demetech Corp.
K140127	FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP	May 28, 2014	Substantially Equivalent	Pontis Orthopaedics, LLC
K081060	FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5	Dec 24, 2008	Substantially Equivalent	Core Essence Orthopaedics, LLC
K082828	SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE	Oct 14, 2008	Substantially Equivalent	Suturtek Incorporated
K063603	SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17	Feb 07, 2007	Substantially Equivalent	Suturtek Incorporated
K042606	MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE	May 27, 2005	Substantially Equivalent	Synthes (Usa)
K041333	SYNTHES (USA) TITANIUM WIRE	Aug 27, 2004	Substantially Equivalent	Synthes (Usa)
K032468	SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE	Sep 23, 2003	Substantially Equivalent	Suturtek Incorporated
K023594	TENO FIX	May 15, 2003	Substantially Equivalent	Ortheon Medical, LLC
K030351	STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE	Mar 28, 2003	Substantially Equivalent	Cp Medical
K023411	STEELEX STERNUM SET	Dec 19, 2002	Substantially Equivalent	Aesculap, Inc.
K022777	MANUAL TOUCHE SYSTEM	Nov 19, 2002	Substantially Equivalent	Onux Medical, Inc.
K013059	STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)	Oct 22, 2001	Substantially Equivalent	Stony Brook Surgical Innovations, Inc.
K991073	ACIER SUTURES	Jul 30, 1999	Substantially Equivalent	Cardio Thoracic Systems
K984151	STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP	Apr 28, 1999	Substantially Equivalent	Mill Pond, Inc.
K955723	STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)	Feb 27, 1996	Substantially Equivalent for Some Indications	Davis & Geck, Inc.
K946173	STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK	Jan 09, 1995	Substantially Equivalent	ETHICON, Inc.
K930740	SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL	Jul 26, 1994	Substantially Equivalent	Deknatel, Inc.
K931915	STAINLESS STEEL SUTURE	Mar 03, 1994	Substantially Equivalent	Surgimetrics International, Ltd.
K931271	ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE	Jan 07, 1994	Substantially Equivalent	ETHICON, Inc.
K933686	LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE	Dec 23, 1993	Substantially Equivalent	Look, Inc.
K930992	FLEXON AND STAINLESS STEEL SUTURES	Dec 17, 1993	Substantially Equivalent	American Cyanamid Co.
K930940	LUKENS STAINLESS STEEL SURGICAL SUTURE	Dec 17, 1993	Substantially Equivalent	Lukens Medical Corp.
K913185	STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT	Dec 04, 1991	Substantially Equivalent	Internacional Farmaceutica, S.A. DE C.V.
K913155	LEG URINAL	Sep 16, 1991	Substantially Equivalent	Ezmt Valve Co., Inc.
K910067	PTI STERNAL CLOSURE WIRE SUTURE	May 06, 1991	Substantially Equivalent	Pioneering Technologies, Inc.
K873645	STAINLESS 22-13-5 SUTURE WIRE	Nov 17, 1987	Substantially Equivalent	Zimmer, Inc.
K865038	SURGISTEEL	Jun 30, 1987	Substantially Equivalent	Sutures , Ltd.