510(k) Report

Devices descending from K131852

4 later devices reach HC-1 and HC-1 Classic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus20180—
+1K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…Colonplus Equipments & Speculums, S.L.20160—
+1K150381Aqua CleanseQuality Medical Supply, Inc.20151—
+2K201861Bio Fluff SystemGnali Bocia S.R.L.20220—