Disposable Stone Retrieval Balloon Catheter
FDA 510(k) clearance K253013 · decided 2026-05-08
Clearance details
- K-number
- K253013
- Device name
- Disposable Stone Retrieval Balloon Catheter
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-19
- Decision date
- 2026-05-08
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- GCA
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.