DeviceClearance

Product code LKY— Gastroenterology, Urology

ERCO-RIBBON

Classification name
Device, External Penile Rigidity
Device class
Class 2
Regulation
21 CFR 876.5020
Advisory panel
Gastroenterology, Urology
Total cleared
87
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code LKY under 21 CFR 876.5020, via openFDA

Market context for product code LKY

FDA has cleared 87 devices under product code LKY between 1983 and 2004, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LKY

Recent clearances under product code LKY

Data sourced from openFDA. This site is unofficial and independent of the FDA.