510(k) Report

Devices descending from K111765

4 later devices reach Full Core Biopsy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140137Safety Biopsy Needle SystemPfm Medical, Inc.20143—
+2K160423Perineologic Access NeedleCorbin Clinical Resources, LLC20162—
+3K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd.20211—
+4K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.20260—