510(k) Report

Devices descending from K082114

2 later devices reach Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+1K093279Navix Access DeviceXlumena201001