IWG — Seed, Isotope, Gold, Titanium, Platinum Class II

FDA Device Classification

FDA product code IWG covers "Seed, Isotope, Gold, Titanium, Platinum", a Class II medical device regulated under 21 CFR 892.5730. Submissions are reviewed by the Radiology panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IWG
Device Class
Class II
Regulation Number
892.5730
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K081066medi-physics, inc., dba ge healthcareBRACHYTHERAPY SOURCE DEVICE, MODEL 9011May 5, 2008
K982421international isotopesIMAGYN 125 I SEED, MODEL IS 125July 31, 1998
K834027radiation safety and nuclear productsGOLD SEADSDecember 27, 1983