K243039
- 510(k) number
- K243039
- Device name
- Ureteral Stents (AF-D series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd. CN
- Product code
- FAD — Stent, Ureteral
- Decision date
- 2025-06-18
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243039.pdf
Official FDA record: K243039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.