GCA
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253013 | 2026-05-08 | Zhejiang Soudon Medical Technology Co.… | Disposable Stone Retrieval Balloon Catheter | |
| K232752 | 2024-02-26 | Jiangsu Vedkang Medical Science and Te… | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-… |
Official FDA classification page: GCA
Classification and pathway per current FDA publications. Data from openFDA (CC0).