Atlas FDA

GAL

30 FDA 510(k) clearances · Product code

163 daysmedian time to decision
386 days90th percentile
30clearances measured

FDA profile

Official device name
Suture, Absorbable, Natural
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4830
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 120 · 2022: 130 · 2023: 121 · 2024: 161 · 2025: 120 · 2026: 75
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Surgical Gut Suture (K142656)Covidien2015-01-29
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (K072930)Demetech Corp.2008-04-30
UNIPLAIN & UNICHROM (K042287)United Medical Industries Co. , Ltd.2005-09-07
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (K042897)Ethicon Endo-Surgery, Inc.2004-11-19
SUTURTEK FASTCLOSE SUTURING DEVICE (K030227)Suturtek Incorporated2003-03-17
SERRALGUT (K020597)Serral, S.A. DE C.V.2002-08-14
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (K021043)Gramsmed, LLC2002-06-21
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (K011105)Qrc Consulting2001-05-30
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (K001299)Cp Medical2000-06-23
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (K000542)Arc Medical Supplies (Beijing) Co, Ltd.2000-04-28
LIGA-LOOP SUTURE APPLICATOR (K993695)Hysterx, Inc.2000-04-13
PLAIN/CHROMIC CATGUT (K994002)Trading Consultants and Distributors Intl., Inc.2000-02-04
AILEE SUTURES AND AILEE NEEDLES (K982646)Myco Medical Supplies, Inc.1999-06-02
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC (K991223)Aesculap, Inc.1999-04-30
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP (K961931)R. K. Medical L. L. C.1996-07-29
PLAIN CATGUT (K943217)Sutures , Ltd.1994-12-05
CHROMIC CATGUT (K943218)Sutures , Ltd.1994-12-05
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (K930738)Deknatel, Inc.1994-07-26
SURGICAL SUTURE PACKAGE INSERTS (K930416)United States Surgical, A Division of Tyco Healthc1994-04-28
CATGUT SUTURE PLAIN (K931918)Surgimetrics International, Ltd.1994-03-03
CATGUT SUTURE CHROMIC (K931919)Surgimetrics International, Ltd.1994-03-03
REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (K926586)Look, Inc.1993-12-22
LUKENS SURGICAL GUT SUTURE (K930944)Lukens Medical Corp.1993-12-17
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR (K930589)Davis & Geck, Inc.1993-12-17
STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES (K911354)Internacional Farmaceutica, S.A. DE C.V.1991-10-25
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP (K904588)United States Surgical, A Division of Tyco Healthc1990-12-24
PLAIN AND CHROMIC GUT SUTURE (K903624)Look, Inc.1990-09-18
ENDOSCOPIC HEMOSTATIC LIGATING LOOP (K902731)United States Surgical, A Division of Tyco Healthc1990-09-07
GUT SUTURES (K896554)Look, Inc.1990-05-31
ABSORBABLE SURGICAL GUT SUTURE* (K885018)United States Surgical, A Division of Tyco Healthc1989-08-22

Track GAL automatically

Every clearance here is in the API, with alerts when new ones post.