510(k) Report

Devices descending from K150852

8 later devices reach SIC 8000 through their predicates, nearest generation first.

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