510(k) Report

Devices descending from K831531

5 later devices reach Surgical Isolation Barrier System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092801Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC20114—
+2K123006Air Barrier System (Abs)Nimbic Systems, Inc.20133—
+3K153498OperioToul Meditech AB20162—
+4K173349OperioToul Meditech AB20170—
+4K163455SurgiCubeSurgicube International B.V.20170—