510(k) Report

Devices descending from K113202

8 later devices reach Tissue Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143484BioZorb MarkerFocal Therapeutics20157Class I
+2K192371BioZorb SP MarkerFocal Therapeutics20190—
+2K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC20180—
+2K180640SmartClip Soft Tissue MarkerElucent Medical, Inc.20181—
+2K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+2K152070BioZorb LP MarkerFocal Therapeutics20155Class I
+3K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.20240—
+3K180621EchoMark, EchoMark LPSonavex, Inc.20180—