510(k) Report

Devices descending from K090501

27 later devices reach Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC20133—
+1K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical201315—
+1K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC201210—
+2K210752HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202151
+2K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.20162—
+2K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,201613—
+2K132463Cianna Medical Permanent Tissue Marker and Delivery SystemCianna Medical, Inc.20130—
+3K222832Sentimag SystemEndomagnetics Ltd.,20230—
+3K212158HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.202241
+3K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20200—
+3K173587Magseed Magnetic Marker SysttemEndomagnetics Ltd.,20182—
+3K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.20170—
+3K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,201712—
+4K232865Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,202402
+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—
+4K210600MOLLIMolli Surgical, Inc.20215—
+4K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20212—
+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—
+5K223107MOLLI 2Molli Surgical, Inc.20234—
+5K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20221—
+6K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.20230—
+6K231579MOLLI 2Molli Surgical, Inc.202331
+7K234149MOLLI 2 SystemMolli Surgical, Inc.20240—
+7K240042MOLLI 2 SystemMolli Surgical, Inc.20241—
+8K253888MOLLI 2 SystemStryker Endoscopy202501