510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IWOClass I

Apron, Protective

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

IWO is the FDA product code for Apron, Protective, a class I device type, regulated under 21 CFR 892.6500. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 13 recalls.

Classification record

Product code
IWO
Device name
Apron, Protective
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
1
Ingested recalls
13

Clearances, product code IWO

By decision year
1 clearance under product code IWO with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IWO by decision year
YearClearances
19771

Applicants with the most clearances

Product code IWO
Applicants holding the most 510(k) clearances under product code IWO
ApplicantClearances
Worldwide Dental, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 80 companies shown, in name order