FDA-Device2022-08-10Class II
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Neotract Inc
Hazard
There is the potential that during implant deployment, the device may not properly deliver a implant.
Sold states
US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None
Affected count
18,722 systems
Manufactured in
4155 Hopyard Rd, N/A, Pleasanton, CA, United States
Products
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2022Don't want to check this manually?
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