510(k) Report

Devices descending from K863385

2 later devices reach (Roth)Spiral Rotating Prostatic Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc.20041—
+2K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—