FDA product code OKZ: Endometrial Sampling Kit
OKZ is the FDA product code for endometrial sampling kit. It is a Class II device, regulated under 21 CFR 884.1175 and reviewed by the Obstetrics and Gynecology panel. Devices under OKZ 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 | Endometrial Sampling Kit |
| Device class | Class II |
| Regulation | 21 CFR 884.1175 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for OKZ devices
openFDA lists no recalls for product code OKZ.
Frequently asked questions
What is FDA product code OKZ?
OKZ is the FDA product code for endometrial sampling kit. It is a Class II device, regulated under 21 CFR 884.1175 and reviewed by the Obstetrics and Gynecology panel.
What device class is OKZ?
Class II, regulation 21 CFR 884.1175. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OKZ
- Run a recall and safety report across every OKZ manufacturer
- Watch product code OKZ 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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