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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K213334
Device Name Monarch Platform, Urology
Applicant
Auris Health, Inc.
150 Shoreline Dr.
Redwood,  CA  94065
Applicant Contact Angela Wong
Correspondent
Auris Health, Inc.
150 Shoreline Dr.
Redwood,  CA  94065
Correspondent Contact Angela Wong
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Codes
FGA   GCB   LJE   LJH  
Date Received10/06/2021
Decision Date 04/29/2022
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
Recalls CDRH Recalls
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