Implanted Tibial Electrical Urinary Continence Device
The implanted tibial electrical urinary continence device (product code QXM) is a Class 2 implantable prescription device in the Gastroenterology/Urology specialty (regulation 876.5305) that receives power from a non-implanted external power source to deliver electrical stimulation to the tibial nerve near the ankle. It is indicated for the treatment of overactive bladder-related symptoms including urge urinary incontinence, urinary urgency, urinary frequency, and nocturia, and requires 510(k) clearance. It is classified as an implant but is not life-sustaining.
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Basic Information
- Product Code
- QXM
- Device Class
- FDA class 2
- Regulation Number
- 876.5305
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.