Gouge, Nasal, Ent
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.
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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
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.