510(k) Report

Devices descending from K193292

4 later devices reach Voyant 5mm Fusion Device, Voyant Maryland Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+1K200598Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20201—
+2K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—
+2K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation20220—