510(k) K253013
Disposable Stone Retrieval Balloon Catheter by
Zhejiang Soudon Medical Technology Co., Ltd.
— Product Code GCA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2026
- Date Received
- September 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type