Stone Extraction Baskets
FDA 510(k) clearance K230598 · decided 2023-09-12
Clearance details
- K-number
- K230598
- Device name
- Stone Extraction Baskets
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-03
- Decision date
- 2023-09-12
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- LQR
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Changzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.