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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 K212202
Device Name WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
OTU Medical INC.
2231 A Fortune Drive
San Jose,  CA  95131
Applicant Contact Geping Liu
Zi-medical, Inc.
93 Springs Rd
Bedford,  MA  01730
Correspondent Contact Mingzi Hussey
Regulation Number876.1500
Classification Product Code
Date Received07/14/2021
Decision Date 04/13/2022
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