Tracheotome
A tracheotome is a surgical instrument used to create an opening in the trachea (tracheotomy), typically to establish or maintain an airway in patients who cannot breathe adequately through the normal upper airway. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LJW, regulated under 21 CFR 874.4420, within the Ear, Nose, and Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LJW
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.