510(k) Report

Devices descending from K040961

24 later devices reach Injector Needle/Snare through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111495Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc.20119—
+1K092090Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc.200913—
+2K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.201512—
+2K150852SIC 8000Cosmo Technologies, Ltd.20158—
+3K243120HybridAPC probeErbe Elektromedizin GmbH20251—
+3K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH20231—
+3K220434Blue Eye (TS-905)The Standard Co., Ltd.20221—
+3K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.20200—
+3K191923EverLift Submucosal Lifting AgentGi Supply20201—
+3K191254EndoClotEndoclot Plus Co., Ltd.20201—
+3K180068ORISE GelBoston Scientific201811
+3K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.201772
+4K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd.20260—
+4K253915MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH20250—
+4K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation20250—
+4K241591Blue EyeThe Standard Co., Ltd.20240—
+4K232033HYBRIDknife® flexErbe Elektromedizin GmbH20230—
+4K212999Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd.20220—
+4K200404ORISE ProKnifeBoston Scientific Corporation20200—
+4K202376EverLift Submucosal Lifting AgentGi Supply, Inc.20200—
+4K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd.20201—
+4K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200—
+4K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp.201913
+5K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—