Probe, Ent
An ENT probe is a slender, elongated instrument used to explore, identify, or assess passages and cavities of the ear, nose, and throat, including the examination of sinuses, the Eustachian tube, or other structures. It is classified as an FDA Class 1 device, the lowest risk tier, and is subject only to general controls without a premarket clearance requirement. Product code KAK is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KAK
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K822277 | ROSEN'S STAPES NEEDLE EXPLORER | Aug 25, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 90 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 90 registration numbers. Click on an entry to view related FDA registrations.