Blower, Powder, Ent
An ENT powder blower is a device used to deliver powdered medicaments or insufflating agents to targeted sites within the ear, nose, or throat, typically for topical treatment of inflammatory or infectious conditions. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KCL 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.
Research product code KCL in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KCL
- Device Class
- FDA class 1
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.