510(k) Report

Devices descending from K012864

9 later devices reach Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation201772
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K222006Sclerotherapy & Endoscopic NeedlesG-Flex Europe Sprl20230—
+2K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd.20221—
+2K190032Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd.20203—
+3K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt, Ltd.20250—
+3K232442Disposable Endoscope Injection NeedlesZhejiang Soudon Medical Technology Co., Ltd.20230—
+3K212668Sclerotherapy NeedleZhejiang Chuangxiang Medical Technology Co., Ltd.20221—
+4K232826Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…Steris20240—