Brachial Plexus Anesthesia Kit
The Brachial Plexus Anesthesia Kit is a convenience kit containing components used to perform brachial plexus nerve block anesthesia, a regional technique for upper limb surgery or pain management. It is classified as FDA Class 2 under regulation 21 CFR 868.5140 within the Anesthesiology medical specialty, and under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance is subject to enforcement discretion, exempting it from 510(k) requirements when all criteria are met. The product code is OGA. It is not designated as an implant or life-sustaining device.
Research product code OGA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OGA
- Device Class
- FDA class 2
- Regulation Number
- 868.5140
- 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 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.