21 CFR 876.5280 — Device, Incontinence, Mechanical/Hydraulic

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5280

Identification

An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate the pad or cuff to pass on the urethra.

Classification Rationale

Class III (premarket approval).

Product Codes