510(k) Report

Devices descending from K994272

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111529Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core…Insert Molding Solutions, Inc.20112—
+1K093399Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520Inrad20090—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+3K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—