FDA product code JXH: Methyl Methacrylate For Aneurysmorrhaphy
JXH is the FDA product code for methyl methacrylate for aneurysmorrhaphy. It is a Class II device, regulated under 21 CFR 882.5030 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under JXH, from 3 different applicants. The average 510(k) review took 35 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Methyl Methacrylate For Aneurysmorrhaphy |
| Device class | Class II |
| Regulation | 21 CFR 882.5030 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every JXH clearance
Top JXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 1 | 2007-07-26 |
| Karlin Technology, Inc. | 1 | 1988-06-17 |
| Dentsply Intl. | 1 | 1987-10-26 |
Most recent JXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071776 | Codman & Shurtleff, Inc. | ANEUROPLASTIC, MODEL 43-1290 | 2007-07-26 | 27 |
| K882072 | Karlin Technology, Inc. | ORTHOPAEDIC AND SPINAL RING CURRETTES | 1988-06-17 | 31 |
| K873688 | Dentsply Intl. | ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL | 1987-10-26 | 46 |
Recalls for JXH devices
openFDA lists no recalls for product code JXH.
Frequently asked questions
What is FDA product code JXH?
JXH is the FDA product code for methyl methacrylate for aneurysmorrhaphy. It is a Class II device, regulated under 21 CFR 882.5030 and reviewed by the Neurology panel.
What device class is JXH?
Class II, regulation 21 CFR 882.5030. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXH?
Across 3 cleared submissions the average was 35 days from receipt to decision (median 31).
Which companies have the most JXH clearances?
Codman & Shurtleff, Inc. (1); Karlin Technology, Inc. (1); Dentsply Intl. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JXH
- Run a recall and safety report across every JXH manufacturer
- Watch product code JXH 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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