510(k) Report

Devices descending from K021847

11 later devices reach Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd.20149—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+2K180363Clear-Tip EUS-FNAFinemedix Co., Ltd.20180—
+2K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+3K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+3K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+3K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+3K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+4K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+4K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—