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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K150183
Device Name ApexM
Applicant
Incontrol Medical, LLC
3225 Gateway Rd.
Suite 250
Brookfield,  WI  53045
Applicant Contact Jessica Andreshak
Correspondent
Incontrol Medical, LLC
3225 Gateway Rd.
Suite 250
Brookfield,  WI  53045
Correspondent Contact Jessica Andreshak
Regulation Number876.5320
Classification Product Code
KPI  
Date Received01/27/2015
Decision Date 04/09/2015
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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