K241956
- 510(k) number
- K241956
- Device name
- Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
- Applicant
- Hunan Endoso Life Technology Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-01-22
- Date received
- 2024-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241956.pdf
Official FDA record: K241956
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.