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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
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
2227 Douglas Rd.
Burnaby,  CA V5C 5A9
Applicant Contact Curtis Jensen
Correspondent
Verathon Medical (Canada) Ulc
2227 Douglas Rd.
Burnaby,  CA V5C 5A9
Correspondent Contact Curtis Jensen
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
FET  
Date Received11/21/2025
Decision Date 05/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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