Nasal Spray, Ent Delivery
An ENT nasal spray delivery device is a mechanical device used to atomize and deliver liquid medications into the nasal cavity, intended to treat nasal conditions such as allergic rhinitis, nasal congestion, or mucosal inflammation. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KCO 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
- KCO
- 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 |
|---|---|---|---|---|
| K760674 | SYN-O-SCOPE NASAL INHALER | Mar 10, 1977 | Substantially Equivalent | Mcdonald and Assoc., Inc. |
FEI Numbers
This FDA classification entry is associated with 73 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 73 registration numbers. Click on an entry to view related FDA registrations.