Product Code: GAS FDA class 2 21 CFR 878.5000

Suture, Nonabsorbable, Synthetic, Polyester

General, Plastic Surgery

The Suture, Nonabsorbable, Synthetic, Polyester (product code GAS) is a durable synthetic suture made from polyester material, used in general and plastic surgery for applications requiring permanent or long-lasting tissue support, such as cardiac, vascular, or orthopedic procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.5000 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is embedded within 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: GAS
Device Class: FDA class 2
Regulation Number: 878.5000
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 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203120	RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene	Nov 24, 2020	Substantially Equivalent	Lsi Solutions, Inc.
K203081	RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture	Nov 24, 2020	Substantially Equivalent	Lsi Solutions
K091018	ARTHREX BIOWIRE	Jul 30, 2010	Substantially Equivalent	Arthrex, Inc.
K002261	MR-III	Oct 23, 2000	Substantially Equivalent	Smith & Nephew, Inc.
K953128	SUTURE CORD	Feb 09, 1996	Substantially Equivalent for Some Indications	Phoenix Biomedical Corp.
K923161	BRAIDED POLYESTER SUTURE MATERIAL	Dec 30, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K913101	PETERS CARDIOFLON(TM) SUTURE	Aug 12, 1992	Substantially Equivalent	Promedica Products, Inc.
K915089	MITEK QUICKANCHOR(TM), MODIFICATION	Feb 03, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K915081	MITEK SNAP PAK(TM), MODIFICATION	Jan 31, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K903175	ADVANCE SUTURE NONABSORBABLE DACRON SUTURE	Jul 26, 1991	Substantially Equivalent	Advance Suture, Inc.
K905285	IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES	Feb 11, 1991	Substantially Equivalent	Internacional Farmaceutica, S.A. DE C.V.
K905440	FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE	Jan 31, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K904535	LU-TEX II	Jan 30, 1991	Substantially Equivalent	Lukens Medical Corp.
K904436	QUICKANCHOR (TM)	Dec 11, 1990	Substantially Equivalent	Mitek Surgical Products, Inc.
K904263	DACRON R SURGICAL SUTURES	Oct 16, 1990	Substantially Equivalent	Sharppoint, Inc.
K904054	POLYVIOLENE(TM) SUTURE	Oct 03, 1990	Substantially Equivalent	Look, Inc.
K902873	NONABSORBABLE DACRON SURGICAL SUTURE*	Sep 27, 1990	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc