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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
Applicant
OTU Medical, Inc.
2231 A Fortune Dr.
San Jose,  CA  95131
Applicant Contact Geping Liu
Correspondent
Zi-medical, Inc.
93 Springs Rd.,
Bedford,  MA  01730
Correspondent Contact Mingzi Hussey
Regulation Number876.1500
Classification Product Code
FAJ  
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
Predetermined Change
Control Plan Authorized		 No
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