510(k) Report

Devices descending from K993951

4 later devices reach Spot Endoscopic Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+1K042901Endomark Sterile India InkPmt Corp.20050—
+2K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+3K251730LIA Console (542-7)Leadoptik, Inc.20250—