K244001
- 510(k) number
- K244001
- Device name
- KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FBO — Cystourethroscope
- Decision date
- 2025-05-02
- Date received
- 2024-12-26
- 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: K244001.pdf
Official FDA record: K244001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.