510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GALClass II

Suture, Absorbable, Natural

21 CFR 878.4830 / General, Plastic Surgery
FDA source (opens on fda.gov)

GAL is the FDA product code for Suture, Absorbable, Natural, a class II device type, regulated under 21 CFR 878.4830. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GAL
Device name
Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
30
Ingested recalls
5

Clearances, product code GAL

By decision year
30 clearances under product code GAL with a decision year between 1989 and 2015, 1994 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GAL by decision year
YearClearances
19891
19904
19911
19933
19946
19961
19992
20004
20011
20022
20031
20041
20051
20081
20151

Applicants with the most clearances

Product code GAL
Applicants holding the most 510(k) clearances under product code GAL
ApplicantClearances
United States Surgical, A Division of Tyco Healthc4
Look, Inc.2
Surgimetrics International, Ltd.2
Sutures, Ltd.2
Aesculap Inc1
Arc Medical Supplies (Beijing) Co, Ltd.1
Medtronic, Inc.1
Cp Medical1
Davis & Geck, Inc.1
Deknatel, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order