K243653
- 510(k) number
- K243653
- Device name
- KARL STORZ HOPKINS Telescopes for Urology
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-08-13
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243653.pdf
Official FDA record: K243653
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.