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

Dilator, Catheter

21 CFR 878.4200 / General, Plastic Surgery
FDA source (opens on fda.gov)

GCC is the FDA product code for Dilator, Catheter, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GCC
Device name
Dilator, Catheter
Regulation
21 CFR 878.4200
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
5

Clearances, product code GCC

By decision year
5 clearances under product code GCC with a decision year between 1982 and 1998, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GCC by decision year
YearClearances
19821
19891
19901
19921
19981

Applicants with the most clearances

Product code GCC
Applicants holding the most 510(k) clearances under product code GCC
ApplicantClearances
Med Institute, Inc.2
Medical Engineering and Development Institute2
Van-Tec, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 95 companies shown, in name order