Product Code: KTF FDA class 1 21 CFR 874.4420

Punch, Ent

Ear, Nose, Throat

The ENT Punch is a surgical hand instrument used in ear, nose, and throat procedures to cut, remove, or reshape tissue within the upper airway and related structures. It falls under FDA Class 1, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing quality standards, with no premarket submission required. The product code is KTF, regulated under 21 CFR 874.4420, within the Ear, Nose, Throat medical specialty. No special flags apply to this device.

510(k)s
0
FEI Numbers
51
Registration Numbers
51
Unique Applicants
0
Years Active

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Basic Information

Product Code
KTF
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 51 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.