Cleared Traditional

K220126 - Geonic Nasal Aspirator, Geonic Nasal Cleaner (FDA 510(k) Clearance)

K220126 · Geon Corporation · Ear, Nose, Throat device

Feb 2023

Decision

380d

Days

Class 2

Risk

K220126 is an FDA 510(k) clearance for the Geonic Nasal Aspirator, Geonic Nasal Cleaner. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).

Submitted by Geon Corporation (Hsi Hu, Chang Hwa Hsien, TW). The FDA issued a Cleared decision on February 2, 2023, 380 days after receiving the submission on January 18, 2022.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number	K220126 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 2022
Decision Date	February 02, 2023
Days to Decision	380 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement