510(k) Report

Devices descending from K000060

35 later devices reach Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022326Radiomed MarkerRadiomed Corporation200321—
+1K012955Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc.200112—
+2K121964Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10MLAugmenix, Inc.20130—
+2K072219Cytophil Tissue MarkerCytophil, Inc.200810—
+2K031206Radiomed Soft Tissue MarkerRadiomed Corp.200320—
+3K120796Superdimension Nitinol/Gold Fiducial MarkerSuperdimension, Inc.20121—
+3K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc.20109—
+3K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+3K071673Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032Onc Solutions, Inc.20073—
+3K070305Pre-Loaded VisicoilRadiomed Corporation200711—
+4K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+4K173251LumiCoil Platinum Fiducial MarkerBoston Scientific Corporation20170—
+4K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Radiomed Corporation20171—
+4K160209Gold AnchorNaslund Medical AB20162—
+4K133697Breast-Med Tissue MarkerBreast-Med, Inc.20151—
+4K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc.20142—
+4K140835General and Plastic SurgeryScion Medical Technologies, LLC20143—
+4K130763Beacon Tissue MarkerScion Medical Technologies, LLC20135—
+4K123638Pekkton IvoryCendres & Metaux SA20130—
+4K121663ClarityElekta, Ltd.20121—
+4K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+4K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+4K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc.20114—
+4K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+4K091645Gold AnchorNaslund Medical AB20093—
+5K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.20250—
+5K230836SchurSign Tissue MarkerSurgmark GmbH20240—
+5K201117Gold AnchorNaslund Medical AB20201—
+5K170026Radiopaque Tissue MarkerViscus Biologics, LLC20170—
+5K170905Star Tissue MarkerScion Medical Technologies, LLC20170—
+5K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC20150—
+5K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+5K141855ClarityElekta, Ltd.20140—
+5K123137Calypso SystemVarian Medical Systems20123—
+6K213053Gold AnchorNaslund Medical AB20220—