Body Fluid Disposal Kit
The Body Fluid Disposal Kit (product code OKF) is a convenience kit used for the safe disposal of body fluids, falling under General, Plastic Surgery (medical specialty SU) and regulated under 21 CFR 878.4040. It is classified as Class 2, which typically requires a 510(k) premarket notification; however, per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) to market if it meets all criteria outlined in that guidance. The device is not an implant and is not life-sustaining or life-supporting.
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Basic Information
- Product Code
- OKF
- 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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.