LKY

Device, External Penile Rigidity

Product code

LKY

Device name

Device, External Penile Rigidity

Device class

Class 2

21 CFR

21 CFR 876.5020

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.

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