Knife, Ear
FDA product code JYO · 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 |
|---|---|---|---|
| K910212 | Color Doppler Option to Ai 5200 Diag Ultraso SystJYO · Traditional | Acoustic Imaging Technologies Corp. | 07/11/1991SE |
| K841006 | Ear Knife-VariousJYO · Traditional | Premier Dental Products Co. | 05/30/1984SE |
| K840764 | Ear KnivesJYO · Traditional | Sharpoint, Inc. | 05/21/1984SE |
| K833602 | Roller Knife-Transverse -SagittalJYO · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K823911 | Knife Blade TipJYO · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K772384 | Myringotomy KnifeJYO · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772372 | Roller KnifeJYO · Traditional | Edward Weck, Inc. | 01/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1319-2013 Class II | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical…Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the… | Summit Medical, Inc. | 03/27/2013Terminated |