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

Rasp, Surgical, General & Plastic Surgery

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GAC is the FDA product code for Rasp, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GAC
Device name
Rasp, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code GAC

By decision year
2 clearances under product code GAC with a decision year between 1985 and 1988, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GAC by decision year
YearClearances
19851
19881

Applicants with the most clearances

Product code GAC
Applicants holding the most 510(k) clearances under product code GAC
ApplicantClearances
Bowen & Company, Inc.1
Neo Contemporary Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 170 companies shown, in name order