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

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

21 CFR 876.5010 / Gastroenterology, Urology
FDA source (opens on fda.gov)

GCA is the FDA product code for Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, a class II device type, regulated under 21 CFR 876.5010. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GCA
Device name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
26
Ingested recalls
2

Clearances, product code GCA

By decision year
26 clearances under product code GCA with a decision year between 1977 and 2026, 1992 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GCA by decision year
YearClearances
19771
19914
19925
19931
19951
19981
20011
20041
20071
20171
20182
20191
20202
20211
20221
20241
20261

Applicants with the most clearances

Product code GCA
Applicants holding the most 510(k) clearances under product code GCA
ApplicantClearances
Wilson-Cook Medical Inc.7
Boston Scientific Corporation2
United States Endoscopy Group, Inc.2
Anrei Medical (HangZhou) CO., Ltd.1
Applied Vascular Devices, Inc.1
C.R. Bard Inc1
Cathlab Corp.1
Cook Incorporated1
Davol, Inc.1
Davol, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order