Body Fluid Clean Up Kit
The Body Fluid Clean Up Kit (product code OKG) is a convenience kit intended for the cleanup of body fluid spills, regulated under 21 CFR 878.4040 in the General, Plastic Surgery specialty (SU). It is classified as Class 2, which normally requires 510(k) clearance, but per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a premarket notification if all criteria in the guidance are met. The device is neither an implant nor life-sustaining.
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Basic Information
- Product Code
- OKG
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- 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 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.