FDA product code IBD: Hyaluronidase
IBD is the FDA product code for hyaluronidase. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel. Devices under IBD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hyaluronidase |
| Device class | Class I |
| Regulation | 21 CFR 864.4400 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Recalls for IBD devices
openFDA lists no recalls for product code IBD.
Frequently asked questions
What is FDA product code IBD?
IBD is the FDA product code for hyaluronidase. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel.
What device class is IBD?
Class I, regulation 21 CFR 864.4400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IBD
- Run a recall and safety report across every IBD manufacturer
- Watch product code IBD 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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