FDA product code NAW: Microspheres Radionuclide
NAW is the FDA product code for microspheres radionuclide. It is a Class III device, reviewed by the Radiology panel. Devices under NAW reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 5 recalls for NAW devices.
Definition
Approved PMA: P990065
Classification
| Field | Value |
|---|---|
| Device name | Microspheres Radionuclide |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NAW devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2021-07-23.
| Year | Recalls |
|---|---|
| 2021 | 2 |
Frequently asked questions
What is FDA product code NAW?
NAW is the FDA product code for microspheres radionuclide. It is a Class III device, reviewed by the Radiology panel.
What device class is NAW?
Class III. Typical premarket route: PMA.
Have NAW devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2021-07-23.
Next steps
- Run an FDA pathway report with predicate devices for product code NAW
- Run a recall and safety report across every NAW manufacturer
- Watch product code NAW 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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