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

Catheter, Cholangiography

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

GBZ is the FDA product code for Catheter, Cholangiography, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 27 recalls.

Classification record

Product code
GBZ
Device name
Catheter, Cholangiography
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
24
Ingested recalls
27

Clearances, product code GBZ

By decision year
24 clearances under product code GBZ with a decision year between 1978 and 1997, 1993 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code GBZ by decision year
YearClearances
19781
19833
19861
19872
19891
19902
19911
19922
19938
19942
19971

Applicants with the most clearances

Product code GBZ
Applicants holding the most 510(k) clearances under product code GBZ
ApplicantClearances
Applied Medical Resources Corp3
BD Becton Dickinson Vacutainer Systems Preanalytic2
Angiomed U.S., Inc.1
Atrium Medical Corporation1
Boston Scientific Corporation1
Cd Medical, Inc.1
Clarus Medical Systems, Inc.1
Ethicon Endo-Surgery Inc1
Gesco Intl., Inc.1
Intermed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order