510(k) Report

Devices descending from K011402

11 later devices reach Biopsy Site Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113202Tissue MarkerFocal Therapeutics20128—
+1K080698Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGPSenorx, Inc.20081—
+2K143484BioZorb MarkerFocal Therapeutics20157Class I
+2K081170Prostate Tissue MarkerSenorx, Inc.20080—
+3K192371BioZorb SP MarkerFocal Therapeutics20190—
+3K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC20180—
+3K180640SmartClip Soft Tissue MarkerElucent Medical, Inc.20181—
+3K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+3K152070BioZorb LP MarkerFocal Therapeutics20155Class I
+4K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.20240—
+4K180621EchoMark, EchoMark LPSonavex, Inc.20180—