510(k) Report

Devices descending from K083667

3 later devices reach Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc.20162—
+2K262474ND Needle Guidance SystemAccurate Access, LLC20260—
+2K250524Mendaera Guidance SystemMendaera, Inc.20250—