FDA Product Code GCA: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Leading manufacturers include Jiangsu Vedkang Medical Science and Technology Co., Ltd. and Boston Scientific Corporation.
25
Total
25
Cleared
113d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Devices (Product Code GCA)
25 devices
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
About Product Code GCA - Regulatory Context
510(k) Submission Activity
25 total 510(k) submissions under product code GCA since 1977, with 25 receiving FDA clearance (average review time: 113 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
GCA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →