Catheter, Nasopharyngeal
The nasopharyngeal catheter is a flexible tube designed to be introduced through the nose to access and maintain a patent airway in the nasopharynx. It is classified as FDA Class 1, indicating low risk and requiring only general controls without premarket notification. The product code is ENW, regulated under 21 CFR 874.4175 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- ENW
- Device Class
- FDA class 1
- Regulation Number
- 874.4175
- 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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.