FDA product code MIJ: Needle, Tumor Localization
MIJ is the FDA product code for needle, tumor localization. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under MIJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for MIJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Tumor Localization |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for MIJ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-03.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code MIJ?
MIJ is the FDA product code for needle, tumor localization. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is MIJ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Have MIJ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2021-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MIJ
- Run a recall and safety report across every MIJ manufacturer
- Watch product code MIJ 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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