GCA

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

Product code
GCA
Device name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device class
Class 2
21 CFR
21 CFR 876.5010
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
26 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-08.

NumberDecision dateApplicantDevice nameSummary
K2530132026-05-08Zhejiang Soudon Medical Technology Co.…Disposable Stone Retrieval Balloon CatheterPDF
K2327522024-02-26Jiangsu Vedkang Medical Science and Te…Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-…PDF

2 summaries are archived here for direct download.

Official FDA classification page: GCA
Classification and pathway per current FDA publications. Data from openFDA (CC0).