Curette, Ear
FDA product code JYG · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932609 | Ear CuretteJYG · Traditional | Ear Tech, Inc. | 07/21/1993SE |
| K852039 | Flex-Loop Flexible Ear CoretteJYG · Traditional | Bionix Corp. | 06/11/1985SE |
| K841354 | CuretteJYG · Traditional | Treace Medical, Inc. | 07/06/1984SE |
| K841001 | Ear Curette, VariousJYG · Traditional | Premier Dental Products Co. | 05/29/1984SE |
| K823916 | Wax Curette TipJYG · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K822273 | ENT CurrettesJYG · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822006 | Operative Ear Currettes & Related ItemJYG · Traditional | Kelleher Corp. | 08/12/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0925-2025 Class II | ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |