510(k) Report

Devices descending from K001807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121964Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10MLAugmenix, Inc.20130—
+1K032347Biomarc Tissue MarkerCarbon Medical Technologies, Inc.200345—
+1K012955Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc.200112—
+2K133697Breast-Med Tissue MarkerBreast-Med, Inc.20151—
+2K072219Cytophil Tissue MarkerCytophil, Inc.200810—
+2K042296Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc.200444—
+3K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.20250—
+3K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy201210—
+3K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc.20109—
+3K100994Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc.201031
+3K072913Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company200810—
+3K063193Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc.200625—
+4K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.20250—
+4K211590Fiducial MarkerCarbon Medical Technologies, Inc.20210—
+4K192771C4 Fiducial MarkerC4 Imaging, LLC20200—
+4K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+4K141356Echo Tip Ultra Fiducial NeedleWilson-Cook Medical, Inc.20140—
+4K140835General and Plastic SurgeryScion Medical Technologies, LLC20143—
+4K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+4K130763Beacon Tissue MarkerScion Medical Technologies, LLC20135—
+4K123638Pekkton IvoryCendres & Metaux SA20130—
+4K113202Tissue MarkerFocal Therapeutics20128—
+4K110772Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.20115—
+4K102608Securmark Biopsy Site Marking SystemSuros Surgical Systems, Inc. A Hologic Company20100—
+4K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc.200717—
+5K230836SchurSign Tissue MarkerSurgmark GmbH20240—
+5K191797BiomarC Fiducial MarkerCarbon Medical Technologies20190—
+5K180037Beacon EUS Access SystemCovidien, LLC201802
+5K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+5K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+5K170026Radiopaque Tissue MarkerViscus Biologics, LLC20170—
+5K170905Star Tissue MarkerScion Medical Technologies, LLC20170—
+5K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC20150—
+5K143484BioZorb MarkerFocal Therapeutics20157Class I
+5K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+5K141722Carefusion Gold Tissue MarkerCare Fusion20150—
+5K132064Biomarc Fiducial MarkerCarbon Medical Technologies, Inc.201411
+5K130678Biomarc Gold Fiducial MarkerCarbon Medical Technologies, Inc.20132—
+6K232865Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,202402
+6K222832Sentimag SystemEndomagnetics Ltd.,20230—
+6K192371BioZorb SP MarkerFocal Therapeutics20190—
+6K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC20180—
+6K180640SmartClip Soft Tissue MarkerElucent Medical, Inc.20181—
+6K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+6K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+6K152070BioZorb LP MarkerFocal Therapeutics20155Class I
+7K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.20240—
+7K180621EchoMark, EchoMark LPSonavex, Inc.20180—
+7K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—