FDA product code PUV: Lymph Node Location System During Sentinel Biopsy Procedure
PUV is the FDA product code for lymph node location system during sentinel biopsy procedure. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under PUV reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Locating lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure
Classification
| Field | Value |
|---|---|
| Device name | Lymph Node Location System During Sentinel Biopsy Procedure |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PUV devices
openFDA lists no recalls for product code PUV.
Frequently asked questions
What is FDA product code PUV?
PUV is the FDA product code for lymph node location system during sentinel biopsy procedure. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is PUV?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PUV
- Run a recall and safety report across every PUV manufacturer
- Watch product code PUV 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