Knife, Ent
The ENT Knife is a surgical cutting instrument designed for use in ear, nose, and throat procedures, including incision and excision of soft tissue in the upper airway. It is classified as FDA Class 1, the lowest risk level, subject to general controls only, with no requirement for a 510(k) or premarket approval submission. The product code is KTG, governed by 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
- KTG
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K822280 | ENT KNIFE HANDLES | Aug 30, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822205 | KNIVES, ENT | Aug 30, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822279 | LANCETS FOR EAR SURGERY | Aug 25, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822187 | TONSIL DISSECTORS | Aug 24, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822203 | KNIFE HANDLE | Aug 20, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 98 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 98 registration numbers. Click on an entry to view related FDA registrations.