LKY · Class II · 21 CFR 876.5020

FDA Product Code LKY: Device, External Penile Rigidity

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.

87
Total
87
Cleared
131d
Avg days
1983
Since

FDA 510(k) Cleared Device, External Penile Rigidity Devices (Product Code LKY)

87 devices
1–24 of 87
No devices found for this product code.

About Product Code LKY - Regulatory Context