FDA-Device2018-06-13Class II
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
Hazard
Device was marketed for uses outside the 510(k) clearance.
Sold states
US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Affected count
1820 devices
Manufactured in
8 Spring St, N/A, Stafford Springs, CT, United States
Products
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2052-2018Don't want to check this manually?
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