Ear, Nose, And Throat Surgical Tray
The Ear, Nose, and Throat Surgical Tray is a convenience kit containing instruments and supplies assembled for use in ENT surgical procedures. Classified as FDA Class 1 under regulation 21 CFR 874.4420 within the Ear, Nose, Throat medical specialty, it is subject only to general controls and is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, requiring no 510(k) submission when all criteria are met. The product code is OGR. It is not designated as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGR
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- 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 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.