Ear Wick
FDA product code KCN · Class I (low risk) · 21 CFR 874.5220 · Ear, Nose, Throat
4510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062540 | Nasopore Ear, Models ND04, ND05KCN · Traditional | Polyganics B.V., | 10/18/2006SE |
| K973578 | Invotec Ear Tampon (Wick) W/StringKCN · Traditional | Invotec International, Inc. | 11/06/1997SE |
| K920357 | Ultracell Ear WickKCN · Traditional | Ultracell Medical Technologies, Inc. | 02/01/1993SE |
| K791059 | Pope Oto-Wick, Sterile & Non-SterileKCN · Traditional | Xomed, Inc. | 07/17/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1625-2022 Class II | BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |