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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K243138
Device Name Geon (S2) Nasal Aspirator
Applicant
Geon Corporation
# 12, Gung Ye Rd.
Hsi Hu
Chang Hwa Hsien,  TW 514
Applicant Contact Henry Chen
Correspondent
Geon Corporation
# 12, Gung Ye Rd.
Hsi Hu
Chang Hwa Hsien,  TW 514
Correspondent Contact Henry Chen
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/30/2024
Decision Date 02/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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