510(k) Report

Devices descending from K060413

4 later devices reach Intact Breast Lesion Excision System and Advance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation20142—
+1K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation20083—
+2K152596Intact® Gen2 SystemIntact Medical Corporation20161—
+3K252183Resitu Slider 09 (RESL09)Resitu Medical AB20250—