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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K160198
Device Name UreTron MultiProbe Lithotripter System
Applicant
Med-Sonics Corp.
4960 Pittsburgh Ave., Suite A
Erie,  PA  16509
Applicant Contact Jennifer Rautine
Correspondent
Med-Sonics Corp.
4960 Pittsburgh Ave., Suite A
Erie,  PA  16509
Correspondent Contact Jennifer Rautine
Regulation Number876.4480
Classification Product Code
FFK  
Date Received01/28/2016
Decision Date 02/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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