Product Code: KAQ FDA class 1 21 CFR 874.4420

Gouge, Nasal, Ent

Ear, Nose, Throat

A nasal gouge is a chisel-like ENT instrument with a curved or fluted cutting edge used to cut or shape nasal bone and cartilage during rhinoplasty, septoplasty, or other reconstructive nasal procedures. It is classified as an FDA Class 1 device, subject only to general controls, reflecting its low-risk status and the absence of premarket notification requirements. Product code KAQ 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
50
Registration Numbers
50
Unique Applicants
0
Years Active

Research product code KAQ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
KAQ
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 50 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.