FDA product code FAZ: System, Cryosurgical, Liquid Nitrogen, For Urology
FAZ is the FDA product code for system, cryosurgical, liquid nitrogen, for urology. It is a Class II device, regulated under 21 CFR 878.4350 and reviewed by the General and Plastic Surgery panel. Devices under FAZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Cryosurgical, Liquid Nitrogen, For Urology |
| Device class | Class II |
| Regulation | 21 CFR 878.4350 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for FAZ devices
openFDA lists no recalls for product code FAZ.
Frequently asked questions
What is FDA product code FAZ?
FAZ is the FDA product code for system, cryosurgical, liquid nitrogen, for urology. It is a Class II device, regulated under 21 CFR 878.4350 and reviewed by the General and Plastic Surgery panel.
What device class is FAZ?
Class II, regulation 21 CFR 878.4350. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FAZ
- Run a recall and safety report across every FAZ manufacturer
- Watch product code FAZ 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