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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 K182022
Device Name ApexMV
Applicant
Incontrol Medical, LLC
3225 Gateway Rd.
Suite 250
Brookfield,  WI  53045
Applicant Contact Corey Olson
Correspondent
Incontrol Medical, LLC
3225 Gateway Rd.
Suite 250
Brookfield,  WI  53045
Correspondent Contact Cory Olson
Regulation Number876.5320
Classification Product Code
KPI  
Date Received07/27/2018
Decision Date 03/15/2019
Decision Substantially Equivalent - Kit (SESK)
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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