Emergency Obstetrical Kit
The Emergency Obstetrical Kit (product code OKU) is a Class 1 convenience kit regulated under 21 CFR 884.4520 in the Obstetrics/Gynecology specialty (OB). Class 1 devices are subject only to general controls and are typically the lowest regulatory burden category. Per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this kit type is under enforcement discretion and does not require a 510(k) premarket notification if all guidance criteria are met. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OKU
- Device Class
- FDA class 1
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
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
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.