APEX

Stimulator, Electrical, Non-implantable, For Incontinence

INCONTROL MEDICAL, LLC

The following data is part of a premarket notification filed by Incontrol Medical, Llc with the FDA for Apex.

Pre-market Notification Details

• Device ID: K141158
• 510k Number: K141158
• Device Name: APEX
• Classification: Stimulator, Electrical, Non-implantable, For Incontinence
• Applicant: INCONTROL MEDICAL, LLC 3225 GATEWAY ROAD, SUITE 250 Brookfield, WI 53045
• Contact: Jessica Andreshak
• Correspondent: Jessica Andreshak; INCONTROL MEDICAL, LLC 3225 GATEWAY ROAD, SUITE 250 Brookfield, WI 53045
• Product Code: KPI
• CFR Regulation Number: 876.5320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-05
• Decision Date: 2014-11-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851508007028	K141158	000