510(k) Report

Devices descending from K063193

25 later devices reach Modification to Biomarc Tissue Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192771C4 Fiducial MarkerC4 Imaging, LLC20200—
+1K140835General and Plastic SurgeryScion Medical Technologies, LLC20143—
+1K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+1K130763Beacon Tissue MarkerScion Medical Technologies, LLC20135—
+1K110772Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20115—
+1K100994Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc.201031
+1K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc.200717—
+2K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.20250—
+2K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.20250—
+2K230836SchurSign Tissue MarkerSurgmark GmbH20240—
+2K211590Fiducial MarkerCarbon Medical Technologies, Inc.20210—
+2K191797BiomarC Fiducial MarkerCarbon Medical Technologies20190—
+2K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+2K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+2K170026Radiopaque Tissue MarkerViscus Biologics, LLC20170—
+2K170905Star Tissue MarkerScion Medical Technologies, LLC20170—
+2K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC20150—
+2K141722Carefusion Gold Tissue MarkerCare Fusion20150—
+2K132064Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.201411
+2K130678Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+2K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc.20109—
+3K232865Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,202402
+3K222832Sentimag SystemEndomagnetics Ltd.,20230—
+3K133697Breast-Med Tissue MarkerBreast-Med, Inc.20151—
+3K123638Pekkton IvoryCendres & Metaux SA20130—