FDA product code NNA: Biopsy Device, Percutaneous, Reprocessed
NNA is the FDA product code for biopsy device, percutaneous, reprocessed. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under NNA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Biopsy Device, Percutaneous, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 NNA devices
openFDA lists no recalls for product code NNA.
Frequently asked questions
What is FDA product code NNA?
NNA is the FDA product code for biopsy device, percutaneous, reprocessed. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is NNA?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NNA
- Run a recall and safety report across every NNA manufacturer
- Watch product code NNA 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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