CFlex Cystoscope - Standard Deflection (0570-0455) +2 more— 510(k) K253696

Clearance details

Device name as filed

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)

Applicant

Verathon Medical (Canada) Ulc

Product code

Code FAJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2025-11-21

Decision date

2026-05-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burnaby, CA

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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 →