FDA product code HPW: Probe And Counter, Isotope, For Phosphorus 32
HPW is the FDA product code for probe and counter, isotope, for phosphorus 32. It is a Class II device, regulated under 21 CFR 886.1670 and reviewed by the Ophthalmic panel. Devices under HPW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Probe And Counter, Isotope, For Phosphorus 32 |
| Device class | Class II |
| Regulation | 21 CFR 886.1670 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HPW devices
openFDA lists no recalls for product code HPW.
Frequently asked questions
What is FDA product code HPW?
HPW is the FDA product code for probe and counter, isotope, for phosphorus 32. It is a Class II device, regulated under 21 CFR 886.1670 and reviewed by the Ophthalmic panel.
What device class is HPW?
Class II, regulation 21 CFR 886.1670. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HPW
- Run a recall and safety report across every HPW manufacturer
- Watch product code HPW 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.