ClearanceBrief
510(k) K121125 ยท FGE Stents, Drains And Dilators For The Biliary Ducts

FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

ApplicantFlexible Stenting Solutions, Inc., Eatontown NJ, US
DecisionUnknown, Jul 6, 2012
ReceivedApr 13, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121125

DateFirm and productCodeLinked 510(k)
Oct 1, 2021Cordis Corporation
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified		 FGENone listed
Oct 1, 2021Cordis Corporation
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified		 FGENone listed
Oct 1, 2021Cordis Corporation
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified		 FGENone listed
Oct 1, 2021Cordis Corporation
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified		 FGENone listed
Oct 1, 2021Cordis Corporation
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified		 FGENone listed
Oct 1, 2021Cordis Corporation
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Open, Classified		 FGENone listed
Nov 15, 2017Cordis Corporation
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
Terminated		 FGENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.