510(k) Report

Devices descending from K161940

2 later devices reach Guidewire 0.6 Single Use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+2K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201