K241945
- 510(k) number
- K241945
- Device name
- KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-08-01
- Date received
- 2024-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241945.pdf
Official FDA record: K241945
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.