FDA Product Code QXM: Implanted Tibial Electrical Urinary Continence Device
An Implanted Tibial Electrical Urinary Continence Device Is An Implanted Prescription Device That Receives Power From A Non-implanted External Power Source To Provide Electrical Stimulation Of The Tibial Nerve In Proximity To The Ankle. The Device Is Intended For The Treatment Of Overactive Bladder Related Symptoms Of Urge Urinary Incontinence, Urinary Urgency, Urinary Frequency And Nocturia.
Leading manufacturers include Bluewind Medical , Ltd..
4
Total
3
Cleared
204d
Avg days
2023
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times:
192d avg (recent)
FDA 510(k) Cleared Implanted Tibial Electrical Urinary Continence Device Devices (Product Code QXM)
4 devices
Cleared
Dec 12, 2025
Revi System
Bluewind Medical , Ltd.
Gastroenterology & Urology
134d
Cleared
May 02, 2024
Revi™ System
Bluewind Medical , Ltd.
Gastroenterology & Urology
118d
Not Cleared
Aug 16, 2023
Revi System
Bluewind Medical , Ltd.
Gastroenterology & Urology
315d
About Product Code QXM - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QXM since 2023, with 3 receiving FDA clearance (average review time: 204 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - QXM Product Code
FDA review times for QXM submissions have been consistent, averaging 192 days recently vs 217 days historically.
QXM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →