510(k) Report

Devices descending from K980122

8 later devices reach Manan Soft Tissue Biopsy Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+1K150625Morrison Steerable NeedleApriomed AB20150—
+1K142791Spectra Soft Tissue Biopsy NeedlesSpectra Medical Devices20150—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+1K041638Targetscan Biopsy KitEnvisioneering, LLC20042—
+2K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+2K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC20071—
+3K081323Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818B-K Medical Aps20080—