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..
FDA 510(k) Cleared Implanted Tibial Electrical Urinary Continence Device Devices (Product Code QXM)
About Product Code QXM - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QXM since 2023, with 2 receiving FDA clearance (average review time: 189 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under QXM have taken an average of 134 days to reach a decision - down from 217 days historically, suggesting improved FDA processing for this classification.
QXM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →