Dropper, Ent
An ENT dropper is a simple device used to instill liquid medications, such as eardrops or nasal drops, into the ear, nose, or throat in measured quantities. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KCM 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
- KCM
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K840907 | POST-AID | Aug 02, 1984 | Substantially Equivalent | E.W. Link, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.