510(k) Report

Devices descending from K142477

2 later devices reach Intact Advance and Intact Excision XL, Intact BLES through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152596Intact® Gen2 SystemIntact Medical Corporation20161—
+2K252183Resitu Slider 09 (RESL09)Resitu Medical AB20250—