510(k) Report

Devices descending from K955558

20 later devices reach Gip/Medi-Globe Sclerotherapy Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061222Injectra Injection NeedleMedi-Globe Corp.200616—
+1K042615Carbon Medical Technologies Endoscopic Injection NeedleCarbon Medical Technologies, Inc.20042—
+2K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc.20170—
+2K150434Injection NeedleMicro-Tech (Nanjing) Co., Ltd.20157—
+2K133148Biomarc Coaxial NeedleCarbon Medical Technologies, Inc.20140—
+2K132065Injection NeedleEndochoice, Inc.20146—
+2K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+3K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.20260—
+3K221054Core-InjectorIncore Co., Ltd.20220—
+3K210917Single Use Injection NeedleAnrei Medical (Hangzhou) Co., Ltd.20213—
+3K181690Clear-Jet Injection CatheterFinemedix Co., Ltd.20180—
+3K153625Single Use Injector NM600/610Olympus Medical Systems Corp.2016420
+3K151475EndoChoice Select Injection NeedleEndochoice, Inc.20160—
+4K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…Olympus Medical Systems Corporation20250—
+4K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+4K230925Disposable Injection Needle AF seriesAlton (Shanghai) Medical Instruments Co., Ltd.20230—
+4K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd.20222—
+4K213239Endoscopic Injection NeedleBeijing Zksk Technology Co., Ltd.20220—
+5K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.20250—
+5K232200Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd.20240—