510(k) Report

Devices descending from K970817

78 later devices reach Micromark Clip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC200630—
+1K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Mri Devices Corp.200425—
+1K993785Ultraclip Tissue MarkerInrad2000281
+1K983400Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc199935—
+2K183503EasyMark Tissue MarkerInrad, Inc.20191—
+2K190689SignalMark Breast MarkerView Point Medical, Inc.20190—
+2K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC20133—
+2K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC201210—
+2K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH201021—
+2K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC200927—
+2K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC200928—
+2K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH2008231
+2K072216Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc.200701
+2K022326Radiomed MarkerRadiomed Corporation200321—
+2K012955Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc.200112—
+3K240429Trilogy Tissue MarkerInrad, Inc.20240—
+3K232865Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,202402
+3K210752HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202151
+3K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeSomatex Medical Technologies GmbH20210—
+3K182082Tumark for Eviva, Tumark for BreveraSomatex Medical Technologies GmbH20180—
+3K180443Tumark VisionSomatex Medical Technologies GmbH20180—
+3K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.20162—
+3K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical201315—
+3K121964Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10MLAugmenix, Inc.20130—
+3K120796Superdimension Nitinol/Gold Fiducial MarkerSuperdimension, Inc.20121—
+3K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH201116—
+3K072219Cytophil Tissue MarkerCytophil, Inc.200810—
+3K031206Radiomed Soft Tissue MarkerRadiomed Corp.200320—
+4K212158HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202241
+4K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20200—
+4K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+4K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20170—
+4K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,201613—
+4K132463Cianna Medical Permanent Tissue Marker and Delivery SystemCianna Medical, Inc.20130—
+4K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc.20109—
+4K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+4K071673Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032Onc Solutions, Inc.20073—
+4K070305Pre-Loaded VisicoilRadiomed Corporation200711—
+5K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker…Devicor Medical Products, Inc.20240—
+5K221961HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc.20232—
+5K222832Sentimag SystemEndomagnetics Ltd.,20230—
+5K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+5K173251LumiCoil Platinum Fiducial MarkerBoston Scientific Corporation20170—
+5K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Radiomed Corporation20171—
+5K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,201712—
+5K160209Gold AnchorNaslund Medical AB20162—
+5K133697Breast-Med Tissue MarkerBreast-Med, Inc.20151—
+5K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc.20142—
+5K140835General and Plastic SurgeryScion Medical Technologies, LLC20143—
+5K130763Beacon Tissue MarkerScion Medical Technologies, LLC20135—
+5K123638Pekkton IvoryCendres & Metaux SA20130—
+5K121663ClarityElekta, Ltd.20121—
+5K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+5K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+5K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc.20114—
+5K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+5K091645Gold AnchorNaslund Medical AB20093—
+6K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…Devicor Medical Products, Inc.20260—
+6K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.20250—
+6K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc.20240—
+6K230836SchurSign Tissue MarkerSurgmark GmbH20240—
+6K210600MOLLIMolli Surgical, Inc.20215—
+6K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20212—
+6K201117Gold AnchorNaslund Medical AB20201—
+6K170026Radiopaque Tissue MarkerViscus Biologics, LLC20170—
+6K170905Star Tissue MarkerScion Medical Technologies, LLC20170—
+6K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC20150—
+6K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+6K141855ClarityElekta, Ltd.20140—
+6K123137Calypso SystemVarian Medical Systems20123—
+7K223107MOLLI 2Molli Surgical, Inc.20234—
+7K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20221—
+7K213053Gold AnchorNaslund Medical AB20220—
+8K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20230—
+8K231579MOLLI 2Molli Surgical, Inc.202331
+9K234149MOLLI 2 SystemMolli Surgical, Inc.20240—
+9K240042MOLLI 2 SystemMolli Surgical, Inc.20241—
+10K253888MOLLI 2 SystemStryker Endoscopy202501