FDA product code IWF: Needle, Isotope, Gold, Titanium, Platinum
IWF is the FDA product code for needle, isotope, gold, titanium, platinum. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. Devices under IWF reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for IWF devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Isotope, Gold, Titanium, Platinum |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for IWF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-03-30.
Frequently asked questions
What is FDA product code IWF?
IWF is the FDA product code for needle, isotope, gold, titanium, platinum. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is IWF?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
Have IWF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code IWF
- Run a recall and safety report across every IWF manufacturer
- Watch product code IWF 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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