Product code GAL— General, Plastic Surgery
ABSORBABLE SURGICAL GUT SUTURE*
- Classification name
- Suture, Absorbable, Natural
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 30
- First cleared
- Most recent
Market context for product code GAL
FDA has cleared devices under product code GAL between 1989 and 2015, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2015
- 2008
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1996
- 1994
- 1993
- 1991
- 1990
- 1989
Top applicants under product code GAL
Adverse events under product code GAL
product code GAL- Malfunction
- 681
- Other
- 1
- Total
- 682
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GAL
- K142656 — Surgical Gut Suture
- K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
- K042287 — UNIPLAIN & UNICHROM
- K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
- K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE
- K020597 — SERRALGUT
- K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
- K011105 — SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
- K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
- K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
- K993695 — LIGA-LOOP SUTURE APPLICATOR
- K994002 — PLAIN/CHROMIC CATGUT
- K982646 — AILEE SUTURES AND AILEE NEEDLES
- K991223 — ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
- K961931 — PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
- K943217 — PLAIN CATGUT
- K943218 — CHROMIC CATGUT
- K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
- K930416 — SURGICAL SUTURE PACKAGE INSERTS
- K931918 — CATGUT SUTURE PLAIN
- K931919 — CATGUT SUTURE CHROMIC
- K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES
- K930589 — PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
- K930944 — LUKENS SURGICAL GUT SUTURE
- K911354 — STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
- K904588 — AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
- K903624 — PLAIN AND CHROMIC GUT SUTURE
- K902731 — ENDOSCOPIC HEMOSTATIC LIGATING LOOP
- K896554 — GUT SUTURES
- K885018 — ABSORBABLE SURGICAL GUT SUTURE*
Data sourced from openFDA. This site is unofficial and independent of the FDA.