K243409
- 510(k) number
- K243409
- Device name
- KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FBO — Cystourethroscope
- Decision date
- 2024-11-27
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243409.pdf
Official FDA record: K243409
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.