Cleared Special

Geon (S2) Nasal Aspirator

K243138 · Geon Corporation · Ear, Nose, Throat
Feb 2025
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K243138 is an FDA 510(k) clearance for the Geon (S2) Nasal Aspirator, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Geon Corporation (Chang Hwa Hsien, TW). The FDA issued a Cleared decision on February 4, 2025, 127 days after receiving the submission on September 30, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K243138 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date February 04, 2025
Days to Decision 127 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

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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