QXM — Implanted Tibial Electrical Urinary Continence Device Class II
FDA product code QXM covers "Implanted Tibial Electrical Urinary Continence Device", a Class II medical device regulated under 21 CFR 876.5305. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QXM
- Device Class
- Class II
- Regulation Number
- 876.5305
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
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.