Mirror, Ent
FDA product code KAI · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat
9510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833601 | Antrum & Attic MirrorKAI · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K823915 | Mirror TipKAI · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K822374 | Buckingham Attic & Antrum MirrorKAI · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822261 | Laryngeal MirrorsKAI · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822191 | Head Mirror with HeadbandKAI · Traditional | Kelleher Corp. | 08/20/1982SE |
| K820354 | Atmos Mirror WarmerKAI · Traditional | Jedmed Instrument Co. | 03/01/1982SE |
| K781750 | Mirror WarmerKAI · Traditional | Arleton Technical Products, Inc. | 01/17/1979SE |
| K770054 | Mirror, Naso-PharynxKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
| K770053 | Mirror, LaryngealKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1432-2024 Class II | Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |