Product Code: KCC FDA class 1 21 CFR 874.4420

Bistoury, Tracheal

Ear, Nose, Throat

A tracheal bistoury is a narrow-bladed, probe-pointed surgical knife historically used to incise the trachea in tracheotomy procedures, allowing precise entry into the airway with minimal surrounding tissue injury. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KCC 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
14
Registration Numbers
14
Unique Applicants
0
Years Active

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Basic Information

Product Code
KCC
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 14 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.