510(k) Report

Devices descending from K060769

30 later devices reach Hydromark Biopsy Site Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190689SignalMark Breast MarkerView Point Medical, Inc.20190—
+1K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC20133—
+1K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC201210—
+1K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC200927—
+1K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC200928—
+2K210752HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202151
+2K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.20162—
+2K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical201315—
+3K212158HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202241
+3K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20200—
+3K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20170—
+3K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,201613—
+3K132463Cianna Medical Permanent Tissue Marker and Delivery SystemCianna Medical, Inc.20130—
+4K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker…Devicor Medical Products, Inc.20240—
+4K221961HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc.20232—
+4K222832Sentimag SystemEndomagnetics Ltd.,20230—
+4K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+4K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,201712—
+5K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…Devicor Medical Products, Inc.20260—
+5K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc.20240—
+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