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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 K253905
Device Name PrimeSight UltraView System
Applicant
Cogentix Medical, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Applicant Contact Chanrasmey White
Correspondent
Cogentix Medical, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Correspondent Contact Chanrasmey White
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
HIH  
Date Received12/05/2025
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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