FDA product code IDX: Sieves, Tissue
IDX is the FDA product code for sieves, tissue. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IDX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Sieves, Tissue |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IDX devices
openFDA lists no recalls for product code IDX.
Frequently asked questions
What is FDA product code IDX?
IDX is the FDA product code for sieves, tissue. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDX?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IDX
- Run a recall and safety report across every IDX manufacturer
- Watch product code IDX 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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