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

Gouge, Surgical, General & Plastic Surgery

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

GDH is the FDA product code for Gouge, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GDH
Device name
Gouge, 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
6
Ingested recalls
0

Clearances, product code GDH

By decision year
6 clearances under product code GDH with a decision year between 1976 and 1990, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GDH by decision year
YearClearances
19761
19841
19871
19891
19902

Applicants with the most clearances

Product code GDH
Applicants holding the most 510(k) clearances under product code GDH
ApplicantClearances
United States Surgical, A Division of Tyco Healthc3
Cher Mel Corp.1
V. Mueller O.V. Baxter Healthcare Corp.1
Zinnanti Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 152 companies shown, in name order