FDA Product Code GCA: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Leading manufacturers include Wilson-Cook Medical, Inc., Jiangsu Vedkang Medical Science and Technology Co., Ltd. and Zhejiang Soudon Medical Technology Co., Ltd..
26
Total
26
Cleared
117d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
231d
recently vs 113d historically
FDA 510(k) Cleared Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Devices (Product Code GCA)
26 devices
Cleared
May 08, 2026
Disposable Stone Retrieval Balloon Catheter
Zhejiang Soudon Medical Technology Co., Ltd.
Gastroenterology & Urology
231d
Cleared
Feb 26, 2024
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Gastroenterology & Urology
171d
Cleared
May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
Boston Scientific Corporation
Gastroenterology & Urology
263d
Cleared
Apr 27, 2021
Stone Retrieval Balloon Catheter
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology
54d
Cleared
May 01, 2020
Stone Retrieval Balloon
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology
99d
Cleared
Feb 27, 2020
Fusion Quattro Extraction Balloon
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
27d
Cleared
Dec 13, 2019
Tri-Ex Extraction Balloon with Multiple Sizing
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
10d
Cleared
Jul 06, 2018
Howell D.A.S.H Extraction Balloon with Multiple Sizing
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
219d
Cleared
Jun 22, 2018
Advance Biliary Balloon Catheter
Cook Incorporated
Gastroenterology & Urology
233d
Cleared
Sep 20, 2017
Tri-Ex Extraction Balloon With Multiple Sizing
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
232d
Cleared
Aug 20, 1993
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
Boston Scientific Corp
Gastroenterology & Urology
140d
Cleared
Aug 26, 1992
BARD STONE REMOVAL BALLOON CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
212d
About Product Code GCA - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code GCA since 1977, with 26 receiving FDA clearance (average review time: 117 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - GCA Product Code
Recent submissions under GCA have taken an average of 231 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
GCA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →