Product Code: KCB FDA class 1 21 CFR 874.4420

Tube, Tonsil Suction

Ear, Nose, Throat

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.

510(k)s
1
FEI Numbers
107
Registration Numbers
107
Unique Applicants
1
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K801468 FRAZIER-FERGUSON SUCTION TUBES

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.