510(k) Report

Devices descending from K111495

9 later devices reach Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150852SIC 8000Cosmo Technologies, Ltd.20158—
+2K220434Blue Eye (TS-905)The Standard Co., Ltd.20221—
+2K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.20200—
+2K191923EverLift Submucosal Lifting AgentGi Supply20201—
+2K191254EndoClotEndoclot Plus Co., Ltd.20201—
+2K180068ORISE GelBoston Scientific201811
+3K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd.20260—
+3K241591Blue EyeThe Standard Co., Ltd.20240—
+3K202376EverLift Submucosal Lifting AgentGi Supply, Inc.20200—