Glossopharyngeal Anesthesia Kit
The Glossopharyngeal Anesthesia Kit is a convenience kit containing components used to perform a glossopharyngeal nerve block, a technique that anesthetizes the posterior tongue, pharynx, and related structures, often used to facilitate awake intubation or treat glossopharyngeal neuralgia. Classified as FDA Class 2 under regulation 21 CFR 868.5120 within the Anesthesiology medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are satisfied. The product code is OGF. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGF
- 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
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.