Continuous Brachial Plexus Block Tray
The Continuous Brachial Plexus Block Tray is a convenience kit containing components needed to establish a continuous peripheral nerve catheter at the brachial plexus for sustained regional anesthesia or analgesia. It is classified as FDA Class 2 under regulation 21 CFR 868.5150 within the Anesthesiology medical specialty; under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance it is under enforcement discretion and does not require a 510(k) submission if all criteria are satisfied. The product code is OGC. It is not designated as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGC
- Device Class
- FDA class 2
- Regulation Number
- 868.5150
- 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.