510(k) Report

Devices descending from K111462

6 later devices reach Fixate Tissue Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113805Fixate Tissue BandAnulex Technologies, Inc.20123—
+1K113400Fixate Tissue BandAnulex Technologies, Inc.20114—
+1K112849Fixate Tissue BandAnulex Technologies, Inc.20115—
+2K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…Stimwave Technologies Incorporated20171—
+2K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M.…Anchor Innovation Medical (A.I.M.)20152—
+3K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.20190—