Geonic Nasal Aspirator, Geonic Nasal Cleaner— 510(k) K220126

Substantially Equivalent

Geon Corporation

FDA 510(k) clearance K220126 for Geonic Nasal Aspirator, Geonic Nasal Cleaner, Substantially Equivalent on 2023-02-02. Applicant: Geon Corporation. Device class: 2.

Clearance details

Applicant
Geon Corporation
Product code
Code BTA
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hsi Hu, Chang Hwa Hsien, TW
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BTA

product code BTA
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.