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

Retainer, Surgical

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

GCZ is the FDA product code for Retainer, Surgical, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
GCZ
Device name
Retainer, Surgical
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
5
Ingested recalls
6

Clearances, product code GCZ

By decision year
5 clearances under product code GCZ with a decision year between 1980 and 1990, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GCZ by decision year
YearClearances
19801
19811
19871
19891
19901

Applicants with the most clearances

Product code GCZ
Applicants holding the most 510(k) clearances under product code GCZ
ApplicantClearances
Adept-Med Intl., Inc.3
Edward Weck, Inc.1
Jain Surgical Equipment, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order