DeviceClearance

Product code IWJ— Radiology

AFTER LOADING DEVICE KIT

Classification name
System, Applicator, Radionuclide, Manual
Device class
Class 1
Regulation
21 CFR 892.5650
Advisory panel
Radiology
Total cleared
36
First cleared
Most recent

Market context for product code IWJ

FDA has cleared 36 devices under product code IWJ between 1980 and 2001, filed by 21 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code IWJ

Recent clearances under product code IWJ

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