DeviceClearance

Product code KDN— Gastroenterology, Urology

COSTORSOL

Classification name
System, Perfusion, Kidney
Device class
Class 2
Regulation
21 CFR 876.5880
Advisory panel
Gastroenterology, Urology
Total cleared
44
First cleared
Most recent

Market context for product code KDN

FDA has cleared 44 devices under product code KDN between 1983 and 2026, filed by 22 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 KDN

Recent clearances under product code KDN

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