510(k) Report

Devices descending from K100994

3 later devices reach Preloaded Tissue Marker Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.20250—
+1K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.20250—
+1K211590Fiducial MarkerCarbon Medical Technologies, Inc.20210—