510(k) Report

Devices descending from K011270

6 later devices reach Automated Core Biopsy Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111765Full Core Biopsy SystemPromex Technologies, LLC20114—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K140137Safety Biopsy Needle SystemPfm Medical, Inc.20143—
+3K160423Perineologic Access NeedleCorbin Clinical Resources, LLC20162—
+4K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd.20211—
+5K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.20260—