Product Code: GAL FDA class 2 21 CFR 878.4830

Suture, Absorbable, Natural

General, Plastic Surgery

The Suture, Absorbable, Natural (product code GAL) is a surgical suture made from natural materials that degrades and is absorbed by the body during the healing process, used for closing wounds and approximating tissue in general and plastic surgery. It is classified as FDA Class 2, which requires a 510(k) premarket notification to demonstrate substantial equivalence. The device is regulated under 21 CFR 878.4830 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is embedded within body tissue at the time of application.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GAL
Device Class: FDA class 2
Regulation Number: 878.4830
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 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K142656	Surgical Gut Suture	Jan 29, 2015	Substantially Equivalent	Covidien
K072930	DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT	Apr 30, 2008	Substantially Equivalent	Demetech Corp.
K042287	UNIPLAIN & UNICHROM	Sep 07, 2005	Substantially Equivalent	United Medical Industries Co. , Ltd.
K042897	AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE	Nov 19, 2004	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K030227	SUTURTEK FASTCLOSE SUTURING DEVICE	Mar 17, 2003	Substantially Equivalent	Suturtek Incorporated
K020597	SERRALGUT	Aug 14, 2002	Substantially Equivalent	Serral, S.A. DE C.V.
K021043	GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC	Jun 21, 2002	Substantially Equivalent	Gramsmed, LLC
K011105	SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE	May 30, 2001	Substantially Equivalent	Qrc Consulting
K001299	PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP	Jun 23, 2000	Substantially Equivalent for Some Indications	Cp Medical
K000542	PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP	Apr 28, 2000	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.
K993695	LIGA-LOOP SUTURE APPLICATOR	Apr 13, 2000	Substantially Equivalent	Hysterx, Inc.
K994002	PLAIN/CHROMIC CATGUT	Feb 04, 2000	Substantially Equivalent	Trading Consultants and Distributors Intl., Inc.
K982646	AILEE SUTURES AND AILEE NEEDLES	Jun 02, 1999	Substantially Equivalent	Myco Medical Supplies, Inc.
K991223	ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC	Apr 30, 1999	Substantially Equivalent	Aesculap, Inc.
K961931	PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP	Jul 29, 1996	Substantially Equivalent	R. K. Medical L. L. C.
K943218	CHROMIC CATGUT	Dec 05, 1994	Substantially Equivalent for Some Indications	Sutures , Ltd.
K943217	PLAIN CATGUT	Dec 05, 1994	Substantially Equivalent for Some Indications	Sutures , Ltd.
K930738	SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC	Jul 26, 1994	Substantially Equivalent	Deknatel, Inc.
K930416	SURGICAL SUTURE PACKAGE INSERTS	Apr 28, 1994	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc
K931919	CATGUT SUTURE CHROMIC	Mar 03, 1994	Substantially Equivalent	Surgimetrics International, Ltd.
K931918	CATGUT SUTURE PLAIN	Mar 03, 1994	Substantially Equivalent	Surgimetrics International, Ltd.
K926586	REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES	Dec 22, 1993	Substantially Equivalent	Look, Inc.
K930944	LUKENS SURGICAL GUT SUTURE	Dec 17, 1993	Substantially Equivalent	Lukens Medical Corp.
K930589	PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR	Dec 17, 1993	Substantially Equivalent	Davis & Geck, Inc.
K911354	STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES	Oct 25, 1991	Substantially Equivalent	Internacional Farmaceutica, S.A. DE C.V.
K904588	AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP	Dec 24, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K903624	PLAIN AND CHROMIC GUT SUTURE	Sep 18, 1990	Substantially Equivalent for Some Indications	Look, Inc.
K902731	ENDOSCOPIC HEMOSTATIC LIGATING LOOP	Sep 07, 1990	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc
K896554	GUT SUTURES	May 31, 1990	Substantially Equivalent for Some Indications	Look, Inc.
K885018	ABSORBABLE SURGICAL GUT SUTURE*	Aug 22, 1989	Substantially Equivalent for Some Indications	United States Surgical, A Division of Tyco Healthc