Irrigator, Sinus
A sinus irrigator is an instrument used in ENT procedures to flush saline or other solutions through the paranasal sinuses to remove secretions, debris, or inflammatory material, commonly used in the treatment of sinusitis. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KAR is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KAR
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131177 | SINUFLUSH LAVAGE SYSTEM | Sep 20, 2013 | Substantially Equivalent | Hedgepath, LLC |
| K931398 | GM SWIVEL VIDEO (TM) IRRIGATOR | Aug 30, 1993 | Substantially Equivalent | Gm Engineering, Inc. |
| K861298 | FISCH DRILL IRRIGATOR | Apr 23, 1986 | Substantially Equivalent | Jedmed Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 74 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.