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Implanted Tibial Electrical Urinary Continence Device

FDA product code QXM · 3 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5305
Review panel
GU
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-05-02 – 2026-07-28

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.

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