510(k) Report

Devices descending from K081057

3 later devices reach Intact Breast Lesion Excision System with Intact Excision XL through their predicates, nearest generation first.

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