510(k) Report

Devices descending from K010107

3 later devices reach R Stent Biliary Endoprosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033212Lifestent SDS Biliary EndoprosthesisOrbus Medical Technologies20032—
+2K052132Modification to: Lifestent Valeo Biliary Stent SystemEdwards Lifesciences, LLC20050—
+2K040550Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies20041—