FDA-Device2021-08-25Class II
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Ethicon Endo-Surgery Inc
Hazard
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Sold states
Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.
Affected count
763 eaches
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2021Don't want to check this manually?
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