FDA product code NKW: Actuator, Syringe, For Injector, Reprocessed
NKW is the FDA product code for actuator, syringe, for injector, reprocessed. It is a Class II device, regulated under 21 CFR 870.1670 and reviewed by the Cardiovascular panel. Devices under NKW 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 | Actuator, Syringe, For Injector, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1670 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NKW devices
openFDA lists no recalls for product code NKW.
Frequently asked questions
What is FDA product code NKW?
NKW is the FDA product code for actuator, syringe, for injector, reprocessed. It is a Class II device, regulated under 21 CFR 870.1670 and reviewed by the Cardiovascular panel.
What device class is NKW?
Class II, regulation 21 CFR 870.1670. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKW
- Run a recall and safety report across every NKW manufacturer
- Watch product code NKW 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.