K232911
- 510(k) number
- K232911
- Device name
- KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
- Applicant
- Karl Storz Endovision, Inc. MA · US
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-06-10
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232911.pdf
Official FDA record: K232911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.