KCN — Ear Wick Class I
FDA product code KCN covers "Ear Wick", a Class I medical device regulated under 21 CFR 874.5220. Submissions are reviewed by the Ear, Nose, Throat panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KCN
- Device Class
- Class I
- Regulation Number
- 874.5220
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K062540 | polyganics b.v | NASOPORE EAR, MODELS ND04, ND05 | October 18, 2006 |
| K973578 | invotec international | INVOTEC EAR TAMPON (WICK) W/STRING | November 6, 1997 |
| K920357 | ultracell medical technologies | ULTRACELL EAR WICK | February 1, 1993 |
| K791059 | xomed | POPE OTO-WICK, STERILE & NON-STERILE | July 17, 1979 |