K253696
- 510(k) number
- K253696
- Device name
- CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
- Applicant
- Verathon Medical (Canada) Ulc CA
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-05-11
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K253696.pdf
Official FDA record: K253696
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.