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.
Hobbs Medical, Inc.
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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