510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IWGClass II

Seed, Isotope, Gold, Titanium, Platinum

21 CFR 892.5730 / Radiology
FDA source (opens on fda.gov)

IWG is the FDA product code for Seed, Isotope, Gold, Titanium, Platinum, a class II device type, regulated under 21 CFR 892.5730. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWG
Device name
Seed, Isotope, Gold, Titanium, Platinum
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code IWG

By decision year
3 clearances under product code IWG with a decision year between 1983 and 2008, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IWG by decision year
YearClearances
19831
19981
20081

Applicants with the most clearances

Product code IWG
Applicants holding the most 510(k) clearances under product code IWG
ApplicantClearances
International Isotopes, Inc.1
GE Heathcare, Inc.1
Radiation Safety & Nuclear Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code