510(k) Report

Devices descending from K851838

20 later devices reach Manan Chiba PTC Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021847Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC200211—
+1K980122Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc.19988—
+2K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+2K150625Morrison Steerable NeedleApriomed AB20150—
+2K142791Spectra Soft Tissue Biopsy NeedlesSpectra Medical Devices20150—
+2K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd.20149—
+2K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K041638Targetscan Biopsy KitEnvisioneering, LLC20042—
+3K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+3K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+3K180363Clear-Tip EUS-FNAFinemedix Co., Ltd.20180—
+3K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+3K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC20071—
+4K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+4K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+4K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+4K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+4K081323Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818B-K Medical Aps20080—
+5K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+5K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—