Brush, Cleaning, Tracheal Tube
The tracheal tube cleaning brush is a device used to clean the inner lumen of tracheal tubes, maintaining airway patency and reducing the risk of obstruction in patients requiring airway management. It is classified as FDA Class 1, indicating low risk with only general controls required. The product code is EPE, regulated under 21 CFR 868.5795 in the Anesthesiology specialty. This device is GMP exempt, meaning it is not subject to the full quality system regulation manufacturing requirements.
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Basic Information
- Product Code
- EPE
- Device Class
- FDA class 1
- Regulation Number
- 868.5795
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- 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 67 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.