Regional Anesthesia Kit
The Regional Anesthesia Kit is a convenience kit that assembles the components needed to deliver regional anesthesia techniques, such as peripheral nerve blocks, for surgical or pain management purposes. Classified as FDA Class 2 under regulation 21 CFR 868.5120 within the Anesthesiology specialty, this kit would normally require a 510(k) premarket notification, but the FDA's May 1997 Convenience Kits Interim Regulatory Guidance places it under enforcement discretion, exempting it from 510(k) requirements when all guidance criteria are met. The product code is OFV. It is not designated as an implant or life-sustaining device.
Basic Information
- Product Code
- OFV
- Device Class
- FDA class 2
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- 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.