510(k) Report

Devices descending from K031938

3 later devices reach Gel Mark Iii Biopsy Site Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081085Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GSSenorx, Inc.20082—
+2K131654Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerSenorx, Inc.20131—
+3K153189Beacon Tissue Marker (SE)Scion Medical Technologies, LLC20150—