510(k) Report

Devices descending from K032347

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133697Breast-Med Tissue MarkerBreast-Med, Inc.20151—
+1K042296Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc.200444—
+2K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.20250—
+2K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy201210—
+2K100994Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc.201031
+2K072913Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company200810—
+2K063193Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc.200625—
+3K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.20250—
+3K211590Fiducial MarkerCarbon Medical Technologies, Inc.20210—
+3K192771C4 Fiducial MarkerC4 Imaging, LLC20200—
+3K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+3K141356Echo Tip Ultra Fiducial NeedleWilson-Cook Medical, Inc.20140—
+3K140835General and Plastic SurgeryScion Medical Technologies, LLC20143—
+3K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+3K130763Beacon Tissue MarkerScion Medical Technologies, LLC20135—
+3K113202Tissue MarkerFocal Therapeutics20128—
+3K110772Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20115—
+3K102608Securmark Biopsy Site Marking SystemSuros Surgical Systems, Inc. A Hologic Company20100—
+3K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc.200717—
+4K230836SchurSign Tissue MarkerSurgmark GmbH20240—
+4K191797BiomarC Fiducial MarkerCarbon Medical Technologies20190—
+4K180037Beacon EUS Access SystemCovidien, LLC201802
+4K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+4K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+4K170026Radiopaque Tissue MarkerViscus Biologics, LLC20170—
+4K170905Star Tissue MarkerScion Medical Technologies, LLC20170—
+4K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC20150—
+4K143484BioZorb MarkerFocal Therapeutics20157Class I
+4K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+4K141722Carefusion Gold Tissue MarkerCare Fusion20150—
+4K132064Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.201411
+4K130678Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+4K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc.20109—
+5K232865Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,202402
+5K222832Sentimag SystemEndomagnetics Ltd.,20230—
+5K192371BioZorb SP MarkerFocal Therapeutics20190—
+5K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC20180—
+5K180640SmartClip Soft Tissue MarkerElucent Medical, Inc.20181—
+5K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+5K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+5K152070BioZorb LP MarkerFocal Therapeutics20155Class I
+5K123638Pekkton IvoryCendres & Metaux SA20130—
+6K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.20240—
+6K180621EchoMark, EchoMark LPSonavex, Inc.20180—
+6K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—