DeviceClearance

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

Substantially Equivalent

Verathon Medical (Canada) Ulc

FDA 510(k) clearance K253696 for CFlex Cystoscope - Standard Deflection (0570-0455) +2 more, Substantially Equivalent on 2026-05-11. Applicant: Verathon Medical (Canada) Ulc. Device class: 2.

Summary

Verathon Medical (Canada)'s record covers three items: the CFlex Cystoscope in Standard Deflection (0570-0455) and Reverse Deflection (0570-0456) versions, and the CystoView Monitor (0570-0465). The product code is FAJ, flexible or rigid cystoscopes and accessories.

Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. The submission was a Traditional 510(k).

Verathon filed from Burnaby, Canada. The decision came 171 calendar days after receipt (November 21, 2025 to May 11, 2026).

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
Product code FAJ
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Burnaby, CA
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FAJ

product code FAJ
Injury
533
Malfunction
6,705
Total
7,238

Source: openFDA MAUDE database, through . 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.