510(k) K243138

Geon (S2) Nasal Aspirator by Geon Corporation — Product Code BTA

K243138 is an FDA 510(k) premarket notification submitted by Geon Corporation for the device "Geon (S2) Nasal Aspirator". The FDA issued a decision of Substantially Equivalent on February 4, 2025. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Geon Corporation has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2025
Date Received
September 30, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type