Elevator, Ent
An ENT elevator is a hand instrument used in ear, nose, and throat surgery to lift, separate, or retract soft tissue and periosteum from underlying bone structures during surgical procedures. It is classified as FDA Class 1, indicating low risk, and is subject only to general controls including proper registration, labeling, and manufacturing standards. Product code KAD 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
- KAD
- 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 |
|---|---|---|---|---|
| K841356 | ELEVATOR | Jul 18, 1984 | Substantially Equivalent | Treace Medical, Inc. |
| K822270 | VARIOUS TYPES OF ENT ELEVATORS | Aug 16, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822190 | ENT ELEVATORS | Aug 16, 1982 | Substantially Equivalent | Kelleher Corp. |
| K772399 | DINGMAN ZYGOMA ELEVATOR | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772391 | BOIES NASAL FRACTURE ELEVATOR | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 118 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 118 registration numbers. Click on an entry to view related FDA registrations.