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

Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

21 CFR 882.5300 / Neurology
FDA source (opens on fda.gov)

MYU is the FDA product code for Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, a class II device type, regulated under 21 CFR 882.5300. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MYU
Device name
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code MYU

By decision year
6 clearances under product code MYU with a decision year between 1999 and 2003, 2003 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code MYU by decision year
YearClearances
19991
20001
20034

Applicants with the most clearances

Product code MYU
Applicants holding the most 510(k) clearances under product code MYU
ApplicantClearances
Parallax Medical, Inc.3
Bryan Corp.1
Cardinalhealth1
Vista Scientific, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code