CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)— 510(k) K253696

Substantially Equivalent

Verathon Medical (Canada) Ulc

FDA 510(k) clearance K253696 for CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465), Substantially Equivalent on 2026-05-11. Applicant: Verathon Medical (Canada) Ulc.

Clearance details

Applicant: Verathon Medical (Canada) Ulc
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-21
Decision date: 2026-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.