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

Suture, Absorbable

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

GAK is the FDA product code for Suture, Absorbable, a class II device type, regulated under 21 CFR 878.4830. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GAK
Device name
Suture, Absorbable
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
1
Ingested recalls
0

Clearances, product code GAK

By decision year
1 clearance under product code GAK with a decision year between 1991 and 1991, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GAK by decision year
YearClearances
19911

Applicants with the most clearances

Product code GAK
Applicants holding the most 510(k) clearances under product code GAK
ApplicantClearances
Davis & Geck, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GAK.