Ear Wick
An ear wick is a small, expandable material, often made of compressed sponge or gauze, inserted into the external ear canal to facilitate the delivery of topical medications to the ear canal lining, commonly used in the treatment of otitis externa. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KCN is regulated under 21 CFR 874.5220 in the Ear, Nose, Throat medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
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Basic Information
- Product Code
- KCN
- Device Class
- FDA class 1
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062540 | NASOPORE EAR, MODELS ND04, ND05 | Oct 18, 2006 | Substantially Equivalent | Polyganics B.V., |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Nov 06, 1997 | Substantially Equivalent | Invotec International, Inc. |
| K920357 | ULTRACELL EAR WICK | Feb 01, 1993 | Substantially Equivalent | Ultracell Medical Technologies, Inc. |
| K791059 | POPE OTO-WICK, STERILE & NON-STERILE | Jul 17, 1979 | Substantially Equivalent | Xomed, Inc. |
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.