510(k) Report

Devices descending from K993582

3 later devices reach Modification to Laser-Shield II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.20202—
+2K213028Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.20211—
+3K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.20260—