OKU — Emergency Obstetrical Kit Class I
FDA product code OKU covers "Emergency Obstetrical Kit", a Class I medical device regulated under 21 CFR 884.4520. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- OKU
- Device Class
- Class I
- Regulation Number
- 884.4520
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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