PIH

Urethral Insert With Pump For Bladder Drainage

Product code

PIH

Device name

Urethral Insert With Pump For Bladder Drainage

Device class

Class 2

21 CFR

21 CFR 876.5140

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

The device is intended to empty urine from the bladder under patient control.

Definition text from the FDA device classification database (U.S. federal government work, public domain).