DeviceClearance

Product code KOE— Gastroenterology, Urology

120 FR OPTILUME PROSTATE BALLOON DILATOR

Classification name
Dilator, Urethral
Device class
Class 2
Regulation
21 CFR 876.5520
Advisory panel
Gastroenterology, Urology
Total cleared
27
First cleared
Most recent

Market context for product code KOE

FDA has cleared 27 devices under product code KOE between 1979 and 2020, filed by 16 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 KOE

Recent clearances under product code KOE

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