510(k) Report

Devices descending from K100267

33 later devices reach Fleximarc, Model CM-0.9-2-10-GG-L through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142294FlexiMarc MarkerCortex Manufacturing, Inc.20150—
+1K120796Superdimension Nitinol/Gold Fiducial MarkerSuperdimension, Inc.20121—
+1K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical20113—
+1K102506Mixed Media MarkerCortex Manufacturing, Inc.201125—
+2K192771C4 Fiducial MarkerC4 Imaging, LLC20200—
+2K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+2K143484BioZorb MarkerFocal Therapeutics20157Class I
+2K132463Cianna Medical Permanent Tissue Marker and Delivery SystemCianna Medical, Inc.20130—
+2K131689Mri MarkerC4 Imaging, LLC20131—
+2K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical201315—
+2K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+3K192371BioZorb SP MarkerFocal Therapeutics20190—
+3K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC20180—
+3K180640SmartClip Soft Tissue MarkerElucent Medical, Inc.20181—
+3K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics20170—
+3K171487Sirius MRI Marker NSC4 Imaging, LLC20170—
+3K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,201613—
+3K152070BioZorb LP MarkerFocal Therapeutics20155Class I
+4K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.20240—
+4K222832Sentimag SystemEndomagnetics Ltd.,20230—
+4K180621EchoMark, EchoMark LPSonavex, Inc.20180—
+4K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+4K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,201712—
+5K232865Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,202402
+5K210600MOLLIMolli Surgical, Inc.20215—
+5K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20212—
+6K223107MOLLI 2Molli Surgical, Inc.20234—
+6K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20221—
+7K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20230—
+7K231579MOLLI 2Molli Surgical, Inc.202331
+8K234149MOLLI 2 SystemMolli Surgical, Inc.20240—
+8K240042MOLLI 2 SystemMolli Surgical, Inc.20241—
+9K253888MOLLI 2 SystemStryker Endoscopy202501