510(k) K240037

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 2, 2024

Date Received

January 5, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Implanted Tibial Electrical Urinary Continence Device

Device Class

Class II

Regulation Number

876.5305

Review Panel

GU

Submission Type

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.