Product Code: JZY FDA class 1 21 CFR 874.4420

Knife, Laryngeal

Ear, Nose, Throat

A laryngeal knife is a surgical hand instrument used in ear, nose, and throat procedures to cut or dissect tissue within or around the larynx. It is classified as an FDA Class 1 device, indicating low risk and subjecting it only to general controls such as proper labeling, registration, and good manufacturing practices. Product code JZY 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
35
Registration Numbers
35
Unique Applicants
0
Years Active

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Basic Information

Product Code
JZY
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 35 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.