Tracheostomy Kit
The Tracheostomy Kit is a convenience kit containing the instruments and materials required to create or manage a tracheostomy, a surgical opening in the trachea that provides an artificial airway. Classified as FDA Class 2 under regulation 21 CFR 868.5800 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 met. The product code is OGW. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- OGW
- 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 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.