510(k) Report

Devices descending from K011484

6 later devices reach Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153625Single Use Injector NM600/610Olympus Medical Systems Corp.2016420
+1K142144Disposable Injection NeedleWilson Instruments (Shanghai) Company Limited20150—
+2K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…Olympus Medical Systems Corporation20250—
+2K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd.20222—
+3K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.20250—
+3K232200Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd.20240—