Elevator, Ent
FDA product code KAD · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841356 | ElevatorKAD · Traditional | Treace Medical, Inc. | 07/18/1984SE |
| K822270 | Various Types of ENT ElevatorsKAD · Traditional | Kelleher Corp. | 08/16/1982SE |
| K822190 | ENT ElevatorsKAD · Traditional | Kelleher Corp. | 08/16/1982SE |
| K772399 | Dingman Zygoma ElevatorKAD · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772391 | Boies Nasal Fracture ElevatorKAD · Traditional | Edward Weck, Inc. | 01/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0926-2025 Class II | ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |