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

Source, Wire, Iridium, Radioactive

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

IWA is the FDA product code for Source, Wire, Iridium, Radioactive, a class II device type, regulated under 21 CFR 892.5730. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWA
Device name
Source, Wire, Iridium, Radioactive
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code IWA

By decision year
8 clearances under product code IWA with a decision year between 1977 and 1992, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code IWA by decision year
YearClearances
19771
19854
19881
19891
19921

Applicants with the most clearances

Product code IWA
Applicants holding the most 510(k) clearances under product code IWA
ApplicantClearances
Rads S.L., Inc.2
Syncor Intl. Corp.2
Amersham Corp.1
Cis Radiopharmaceuticals, Inc.1
Omnitron Intl., Inc.1
Radiation Safety & Nuclear Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code IWA.