FDA product code NOK: Material, External Aesthetic Restoration, No Adhesive
NOK is the FDA product code for material, external aesthetic restoration, no adhesive. It is a Class I device, regulated under 21 CFR 878.3800 and reviewed by the General and Plastic Surgery panel. Devices under NOK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
external aesthetic restoration prosthesis
Classification
| Field | Value |
|---|---|
| Device name | Material, External Aesthetic Restoration, No Adhesive |
| Device class | Class I |
| Regulation | 21 CFR 878.3800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NOK devices
openFDA lists no recalls for product code NOK.
Frequently asked questions
What is FDA product code NOK?
NOK is the FDA product code for material, external aesthetic restoration, no adhesive. It is a Class I device, regulated under 21 CFR 878.3800 and reviewed by the General and Plastic Surgery panel.
What device class is NOK?
Class I, regulation 21 CFR 878.3800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NOK
- Run a recall and safety report across every NOK manufacturer
- Watch product code NOK 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times