K243550
- 510(k) number
- K243550
- Device name
- KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-06-06
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243550.pdf
Official FDA record: K243550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.