FDA product code MRJ: Ring, Endocapsular
MRJ is the FDA product code for ring, endocapsular. It is a Class III device, reviewed by the Ophthalmic panel. Devices under MRJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Ring, Endocapsular |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MRJ devices
openFDA lists no recalls for product code MRJ.
Frequently asked questions
What is FDA product code MRJ?
MRJ is the FDA product code for ring, endocapsular. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is MRJ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MRJ
- Run a recall and safety report across every MRJ manufacturer
- Watch product code MRJ 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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