FDA product code OKX: Trocar Kit
OKX is the FDA product code for trocar kit. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel. Devices under OKX 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 | Trocar Kit |
| Device class | Class II |
| Regulation | 21 CFR 884.1720 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for OKX devices
openFDA lists no recalls for product code OKX.
Frequently asked questions
What is FDA product code OKX?
OKX is the FDA product code for trocar kit. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel.
What device class is OKX?
Class II, regulation 21 CFR 884.1720. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OKX
- Run a recall and safety report across every OKX manufacturer
- Watch product code OKX 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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