Cricothyrotomy Kit
The Cricothyrotomy Kit is a convenience kit providing components required to perform an emergency cricothyrotomy, a surgical airway procedure used when conventional intubation is not possible. Classified as FDA Class 2 under regulation 21 CFR 868.5800 within the Anesthesiology medical specialty, it is subject to enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) submission when all criteria are met. The product code is OGP. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGP
- Device Class
- FDA class 2
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Review Panel
- EN
- 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 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.