Product Code: KAW FDA class 1 21 CFR 874.4420

Punch, Antrum

Ear, Nose, Throat

An antrum punch is a surgical instrument used in ENT procedures to enlarge or create openings in the wall of the maxillary sinus (antrum) to facilitate drainage or access during sinus surgery. It is classified as an FDA Class 1 device, the lowest risk category, requiring only general controls and no premarket clearance. Product code KAW 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
52
Registration Numbers
52
Unique Applicants
0
Years Active

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Basic Information

Product Code
KAW
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 52 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.