FDA product code OHF: Culdocentesis Kit
OHF is the FDA product code for culdocentesis kit. It is a Class II device, regulated under 21 CFR 884.1640 and reviewed by the Obstetrics and Gynecology panel. Devices under OHF 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 | Culdocentesis Kit |
| Device class | Class II |
| Regulation | 21 CFR 884.1640 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for OHF devices
openFDA lists no recalls for product code OHF.
Frequently asked questions
What is FDA product code OHF?
OHF is the FDA product code for culdocentesis kit. It is a Class II device, regulated under 21 CFR 884.1640 and reviewed by the Obstetrics and Gynecology panel.
What device class is OHF?
Class II, regulation 21 CFR 884.1640. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OHF
- Run a recall and safety report across every OHF manufacturer
- Watch product code OHF 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.
All Obstetrics and Gynecology product codes · FDA product code lookup