510(k) K243039
K243039 is an FDA 510(k) premarket notification submitted by Alton (Shanghai) Medical Instruments Co., Ltd. for the device "Ureteral Stents (AF-D series)". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Alton (Shanghai) Medical Instruments Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2025
- Date Received
- September 27, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4620
- Review Panel
- GU
- Submission Type