Product Code: KCH FDA class 1 21 CFR 874.4420

Hook, Tracheal

Ear, Nose, Throat

A tracheal hook is a sharp, angled surgical instrument used during tracheotomy to retract and stabilize the tracheal rings, allowing controlled incision of the trachea and safe insertion of a tracheostomy tube. 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 KCH is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

510(k)s
0
FEI Numbers
78
Registration Numbers
78
Unique Applicants
0
Years Active

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Basic Information

Product Code
KCH
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

FEI Numbers

This FDA classification entry is associated with 78 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 78 registration numbers. Click on an entry to view related FDA registrations.