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

Shield, Gonadal

21 CFR 892.6500 / Radiology
FDA source (opens on fda.gov)

IWT is the FDA product code for Shield, Gonadal, a class I device type, regulated under 21 CFR 892.6500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWT
Device name
Shield, Gonadal
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code IWT

By decision year
2 clearances under product code IWT with a decision year between 1983 and 1993, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IWT by decision year
YearClearances
19831
19931

Applicants with the most clearances

Product code IWT
Applicants holding the most 510(k) clearances under product code IWT
ApplicantClearances
Byers Industries, Inc.1
Radiology Design1

Companies listing this code with FDA

Companies whose registered establishments list this code