Adenotome
An adenotome is a surgical cutting instrument used to remove the adenoids, lymphoid tissue located in the posterior nasopharynx, during adenoidectomy procedures typically performed in pediatric patients with recurrent infections or airway obstruction. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls without premarket clearance requirements. Product code KBH 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
- KBH
- 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 |
|---|---|---|---|---|
| K822262 | ADENOTOMES | Aug 25, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.