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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometer, Electrical Recording
510(k) Number K243052
Device Name Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
Applicant
Bright Uro, Inc.
3 Goddard
Irvine,  CA  92618
Applicant Contact Dr. Roychowdhury Suranjan
Correspondent
Bright Uro, Inc.
3 Goddard
Irvine,  CA  92618
Correspondent Contact Dr. Roychowdhury Suranjan
Regulation Number876.1620
Classification Product Code
EXQ  
Subsequent Product Code
EXY  
Date Received09/27/2024
Decision Date 03/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05959655
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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