Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GAL — Predicate Candidate Screening

30 FDA 510(k) clearances under this product code; the 50 most recent screened below.

163 daysmedian FDA review time

386 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142656	Surgical Gut Suture	Covidien	2015-01-29	133	3
K072930	DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT	Demetech Corp.	2008-04-30	197	0
K042287	UNIPLAIN & UNICHROM	United Medical Industries Co. , Ltd.	2005-09-07	379	0
K042897	AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE	Ethicon Endo-Surgery, Inc.	2004-11-19	30	0
K030227	SUTURTEK FASTCLOSE SUTURING DEVICE	Suturtek Incorporated	2003-03-17	54	0
K020597	SERRALGUT	Serral, S.A. DE C.V.	2002-08-14	173	0
K021043	GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC	Gramsmed, LLC	2002-06-21	81	0
K011105	SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE	Qrc Consulting	2001-05-30	49	0
K001299	PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP	Cp Medical	2000-06-23	60	0
K000542	PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP	Arc Medical Supplies (Beijing) Co, Ltd.	2000-04-28	71	0
K993695	LIGA-LOOP SUTURE APPLICATOR	Hysterx, Inc.	2000-04-13	163	0
K994002	PLAIN/CHROMIC CATGUT	Trading Consultants and Distributors Intl., Inc.	2000-02-04	72	0
K982646	AILEE SUTURES AND AILEE NEEDLES	Myco Medical Supplies, Inc.	1999-06-02	308	0
K991223	ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCA	Aesculap, Inc.	1999-04-30	18	0
K961931	PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP	R. K. Medical L. L. C.	1996-07-29	73	0
K943217	PLAIN CATGUT	Sutures , Ltd.	1994-12-05	153	0
K943218	CHROMIC CATGUT	Sutures , Ltd.	1994-12-05	153	0
K930738	SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC	Deknatel, Inc.	1994-07-26	529	9
K930416	SURGICAL SUTURE PACKAGE INSERTS	United States Surgical, A Division of Tyco Healthc	1994-04-28	457	0
K931918	CATGUT SUTURE PLAIN	Surgimetrics International, Ltd.	1994-03-03	321	0
K931919	CATGUT SUTURE CHROMIC	Surgimetrics International, Ltd.	1994-03-03	321	0
K926586	REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES	Look, Inc.	1993-12-22	386	0
K930944	LUKENS SURGICAL GUT SUTURE	Lukens Medical Corp.	1993-12-17	297	0
K930589	PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR	Davis & Geck, Inc.	1993-12-17	316	0
K911354	STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES	Internacional Farmaceutica, S.A. DE C.V.	1991-10-25	213	0
K904588	AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP	United States Surgical, A Division of Tyco Healthc	1990-12-24	89	0
K903624	PLAIN AND CHROMIC GUT SUTURE	Look, Inc.	1990-09-18	41	0
K902731	ENDOSCOPIC HEMOSTATIC LIGATING LOOP	United States Surgical, A Division of Tyco Healthc	1990-09-07	78	0
K896554	GUT SUTURES	Look, Inc.	1990-05-31	195	0
K885018	ABSORBABLE SURGICAL GUT SUTURE*	United States Surgical, A Division of Tyco Healthc	1989-08-22	260	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda