FDA product code MYU: Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MYU is the FDA product code for accessory, barium sulfate, methyl methacrylate for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5300 and reviewed by the Neurology panel. FDA has cleared 6 510(k) submissions under MYU, from 4 different applicants. The average 510(k) review took 105 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
| Device class | Class II |
| Regulation | 21 CFR 882.5300 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MYU clearance
Top MYU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Parallax Medical, Inc. | 3 | 2003-12-12 |
| Cardinalhealth | 1 | 2003-10-31 |
| Vista Scientific, LLC | 1 | 2003-08-08 |
| Bryan Corp. | 1 | 2000-08-10 |
Most recent MYU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033230 | Parallax Medical, Inc. | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | 2003-12-12 | 67 |
| K032388 | Cardinalhealth | BONE CEMENT RADIO-OPACIFIER | 2003-10-31 | 88 |
| K024359 | Vista Scientific, LLC | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | 2003-08-08 | 221 |
| K023445 | Parallax Medical, Inc. | TRACERS BONE CEMENT OPACIFIER | 2003-03-11 | 147 |
| K002063 | Bryan Corp. | BIOTRACE, MODEL 1730 | 2000-08-10 | 34 |
Recalls for MYU devices
openFDA lists no recalls for product code MYU.
Frequently asked questions
What is FDA product code MYU?
MYU is the FDA product code for accessory, barium sulfate, methyl methacrylate for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5300 and reviewed by the Neurology panel.
What device class is MYU?
Class II, regulation 21 CFR 882.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYU?
Across 6 cleared submissions the average was 105 days from receipt to decision (median 80).
Which companies have the most MYU clearances?
Parallax Medical, Inc. (3); Cardinalhealth (1); Vista Scientific, LLC (1); Bryan Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MYU
- Run a recall and safety report across every MYU manufacturer
- Watch product code MYU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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