Product Code: GAR FDA class 2 21 CFR 878.5020

Suture, Nonabsorbable, Synthetic, Polyamide

General, Plastic Surgery

The Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR) is a synthetic, nonabsorbable suture made from polyamide (nylon), used for wound closure and tissue approximation in general and plastic surgery settings where a durable, non-degrading suture is required. It is classified as FDA Class 2, requiring a 510(k) premarket notification. The device is regulated under 21 CFR 878.5020 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is threaded through body tissue during use.

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510(k)s

FEI Numbers

114

Registration Numbers

114

Unique Applicants

Years Active

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Basic Information

Product Code: GAR
Device Class: FDA class 2
Regulation Number: 878.5020
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261484	Tissue Approximation System	Jun 03, 2026	Substantially Equivalent	Tas Medical, Inc.
K220980	Tissue Approximation System (TAS)	Jul 05, 2023	Substantially Equivalent	Tas Medical, Inc.
K212888	Golnit Nylon Monofilament Suture	Mar 31, 2022	Substantially Equivalent	Antarma, LLC Dba Golnit Sutures
K212603	Non Absorbable Surgical Nylon Suture	Dec 22, 2021	Substantially Equivalent	Shandong Haidike Medical Product Co., Ltd.
K192420	Crownjun Nylon Suture	May 29, 2020	Substantially Equivalent	Kono Seisakusho Co., Ltd.
K161633	REXLON, REXSIL	Mar 02, 2017	Substantially Equivalent	Sm Eng Co., Ltd.
K151165	Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture	Feb 17, 2016	Substantially Equivalent	Aesculap, Inc.
K152795	RiverLon (Nylon) Suture	Oct 28, 2015	Substantially Equivalent	Riverpoint Medical
K123034	VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED	May 28, 2013	Substantially Equivalent	Unilene Sac
K081366	KUMAR T-ANCHORS HERNIA SET	Jul 15, 2008	Substantially Equivalent	Nashville Surgical Instruments
K060471	FSSB NYLON SURGICAL SUTURES	Jul 26, 2006	Substantially Equivalent	Fssb Chirurgische Nadeln GmbH
K053637	MANI NEEDLE & SUTURE PACK (NYLON)	May 19, 2006	Substantially Equivalent	Mani, Inc.
K060528	AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE	Mar 28, 2006	Substantially Equivalent	Aesculap, Inc.
K052900	QUILL NONABSORBABLE NYLON BARBED SUTURE	Nov 28, 2005	Substantially Equivalent	Quill Medical, Inc.
K052482	ARTELON SURGICAL SUTURE	Oct 17, 2005	Substantially Equivalent	Artimplant AB
K041510	TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE	Jun 02, 2005	Substantially Equivalent	Sutures India Private Limited
K042284	UNIMIDE	Dec 03, 2004	Substantially Equivalent	United Medical Industries Co. , Ltd.
K042367	NYLON THREADED NEEDLE	Oct 14, 2004	Substantially Equivalent	Aros Surgical Instruments Corp.
K032160	ARTELON SURGICAL SUTURE	Nov 17, 2003	Substantially Equivalent	Artimplant AB
K031531	S&T MICROSURGICAL SUTURE	Sep 23, 2003	Substantially Equivalent	S & T AG
K030177	ORLON NONABSORABLE SURGICAL SUTURE USP	Jul 21, 2003	Substantially Equivalent	Sri Orion Pharmaceuticals & Sutures
K023028	DEMETECH NYLON NONABSORBABLE SUTURE	Jun 18, 2003	Substantially Equivalent	Demetech Corp.
K024090	NYLON SUTURE	Feb 28, 2003	Substantially Equivalent	Aurolab
K020146	SERRALNYL	Apr 15, 2002	Substantially Equivalent	Serral, S.A. DE C.V.
K003000	GRAMS NYLON NONABSORBABLE SUTURE	Dec 18, 2000	Substantially Equivalent	Gramsmed, LLC
K001173	NYLON, NONABSORBABLE SURGICAL SUTURES USP	Jun 23, 2000	Substantially Equivalent for Some Indications	Cp Medical
K000539	NYLON NONABSORBABLE SURGICAL SUTURES, USP	Apr 27, 2000	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.
K993970	MICRINS MICROSURGICAL SUTURE	Mar 30, 2000	Substantially Equivalent	Micrins Surgical, Inc.
K994176	SUTRALON NYLON SUTURES	Feb 08, 2000	Substantially Equivalent	Visionary Medical Supplies, Inc.
K993998	NYLON	Feb 04, 2000	Substantially Equivalent	Trading Consultants and Distributors Intl., Inc.
K990090	DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE	Mar 22, 1999	Substantially Equivalent	Aesculap, Inc.
K981582	SURGILON, DERMALON, & OPHTHALON	Jul 13, 1998	Substantially Equivalent	Davis & Geck, Inc.
K981322	CUTALON NYLON POLYAMIDE SURGICAL SUTURE	Jul 07, 1998	Substantially Equivalent	Genzyme Surgical Product (Genzyme Biosurgery)
K960327	NYLON NOABSORBABLE SURGICAL SUTURES USP	Mar 04, 1996	Substantially Equivalent for Some Indications	R. K. Medical L. L. C.
K943223	SURGIDEK B	Dec 05, 1994	Substantially Equivalent for Some Indications	Sutures , Ltd.
K943222	SURGIDEK S	Dec 05, 1994	Substantially Equivalent for Some Indications	Sutures , Ltd.
K943216	SURGIDEK	Dec 05, 1994	Substantially Equivalent for Some Indications	Sutures , Ltd.
K931914	SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE	Oct 05, 1994	Substantially Equivalent	Surgimetrics International, Ltd.
K932037	SUTURE ABSORBABLE- GUT	Jan 07, 1994	Substantially Equivalent	Surgical Specialties, Inc.
K931613	SUPRAMID SUTURE	Dec 17, 1993	Substantially Equivalent	S. Jackson, Inc.
K931612	NYLAMID SUTURE	Dec 17, 1993	Substantially Equivalent	S. Jackson, Inc.
K930943	LUKENS NYLON SURGICAL SUTURE	Dec 17, 1993	Substantially Equivalent	Lukens Medical Corp.
K930586	DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT	Dec 17, 1993	Substantially Equivalent	Davis & Geck, Inc.
K930517	NON-ABSORBABLE SURGICAL SUTURES	Dec 17, 1993	Substantially Equivalent	Alcon Laboratories
K926587	REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)	Dec 17, 1993	Substantially Equivalent	Look, Inc.
K926168	SILK SUTURES-REVISED LABELING	Dec 17, 1993	Substantially Equivalent	Look, Inc.
K922530	VISITEC MICROSURGICAL SUTURE	Oct 20, 1992	Substantially Equivalent	Visitec Co.
K920510	URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER	Sep 14, 1992	Substantially Equivalent	Uresil Corp.
K913102	PETERS CARDIONYL(TM) SUTURE	Aug 03, 1992	Substantially Equivalent	Promedica Products, Inc.
K912429	N80-838 SUPRAMID EXTRA SUTURE	Oct 02, 1991	Substantially Equivalent	S. Jackson, Inc.
K903177	ADVANCE SUTURE NONABSORBABLE NYLON SUTURE	Jun 28, 1991	Substantially Equivalent	Advance Suture, Inc.
K905286	IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES	Feb 11, 1991	Substantially Equivalent	Internacional Farmaceutica, S.A. DE C.V.
K904931	AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*	Jan 29, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K905379	AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP	Jan 17, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K904052	SUPRAMID EXTRA SUTURES	Oct 25, 1990	Substantially Equivalent	S. Jackson, Inc.
K903029	STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE	Oct 25, 1990	Substantially Equivalent	Look, Inc.
K900531	NONABSORBABLE NYLON SURGICAL SUTURE*	Jul 05, 1990	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc