FDA product code IAW: Collodion
IAW is the FDA product code for collodion. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IAW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Collodion |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IAW devices
openFDA lists no recalls for product code IAW.
Frequently asked questions
What is FDA product code IAW?
IAW is the FDA product code for collodion. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IAW?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IAW
- Run a recall and safety report across every IAW manufacturer
- Watch product code IAW 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.