Orotracheal Intubation Guide Kit
The Orotracheal Intubation Guide Kit is a convenience kit containing components used to facilitate oral endotracheal intubation, including guiding devices that assist in placing the endotracheal tube through the vocal cords. Classified as FDA Class 2 under regulation 21 CFR 868.1400 within the Anesthesiology medical specialty, it falls 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 met. The product code is OGK. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGK
- Device Class
- FDA class 2
- Regulation Number
- 868.1400
- 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 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.