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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 K251140
Device Name Zenflow Spring Scope
Applicant
Zenflow, Inc.
395 Oyster Pt. Blvd.
Suite 501
South San Francisco,  CA  94080
Applicant Contact Marianne Jacklyn
Correspondent
Zenflow, Inc.
395 Oyster Pt. Blvd.
Suite 501
South San Francisco,  CA  94080
Correspondent Contact Marianne Jacklyn
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received04/14/2025
Decision Date 09/23/2025
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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