Implanted Tibial Electrical Urinary Continence Device

QXM · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5305

Classification

FDA Product Code: QXM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5305
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown