K253411
- 510(k) number
- K253411
- Device name
- Miniature Telescope for Urology (27033AA)
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-11-18
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K253411.pdf
Official FDA record: K253411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.