IWA · Class II · 21 CFR 892.5730

FDA Product Code IWA: Source, Wire, Iridium, Radioactive

Leading manufacturers include Syncor Intl. Corp. and Amersham Corp..

8
Total
8
Cleared
92d
Avg days
1977
Since

FDA 510(k) Cleared Source, Wire, Iridium, Radioactive Devices (Product Code IWA)

8 devices
1–8 of 8
Cleared Sep 29, 1989
CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
K894409
Amersham Corp.
Radiology · 74d
Cleared Mar 26, 1985
IRIDIUM 192 WIRES
K850163
Syncor Intl. Corp.
Radiology · 69d
Cleared Mar 26, 1985
WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
K850726
Syncor Intl. Corp.
Radiology · 32d

About Product Code IWA - Regulatory Context