FDA product code NOJ: Prosthesis, Breast, External, No Adhesive
NOJ is the FDA product code for prosthesis, breast, external, 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 NOJ 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 | Prosthesis, Breast, External, 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 NOJ devices
openFDA lists no recalls for product code NOJ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code NOJ?
NOJ is the FDA product code for prosthesis, breast, external, 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 NOJ?
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 NOJ
- Run a recall and safety report across every NOJ manufacturer
- Watch product code NOJ 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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