Tube, Tonsil Suction
A tonsil suction tube is a hollow, angled suction instrument used during tonsillectomy procedures to aspirate blood and secretions from the operative site while simultaneously retracting tonsillar tissue, maintaining visualization of the surgical field. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KCB 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
- KCB
- 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 |
|---|---|---|---|---|
| K801468 | FRAZIER-FERGUSON SUCTION TUBES | Aug 12, 1980 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 107 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 107 registration numbers. Click on an entry to view related FDA registrations.