FDA product code OJW: Shave Prep Kit
OJW is the FDA product code for shave prep kit. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel. Devices under OJW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Shave Prep Kit |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for OJW devices
openFDA lists no recalls for product code OJW.
Frequently asked questions
What is FDA product code OJW?
OJW is the FDA product code for shave prep kit. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel.
What device class is OJW?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OJW
- Run a recall and safety report across every OJW manufacturer
- Watch product code OJW 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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