SCT

Foley Catheters And Accessories With Additional Safety Features

Product code

SCT

Device name

Foley Catheters And Accessories With Additional Safety Features

Device class

Class 2

21 CFR

21 CFR 876.5130

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

FDA classification definition

Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections.

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