Cleared Traditional

Geonic Nasal Aspirator, Geonic Nasal Cleaner

K220126 · Geon Corporation · Ear, Nose, Throat
Feb 2023
Decision
380d
Days
Class 2
Risk

About This 510(k) Submission

K220126 is an FDA 510(k) clearance for the Geonic Nasal Aspirator, Geonic Nasal Cleaner, 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 review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K220126 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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