510(k) Report

Devices descending from K050112

1 later device reach Pro Fit Disposable Rectal Speculum, Models 8116 and 8117 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…Colonplus Equipments & Speculums, S.L.20160—