510(k) Report

Devices descending from K970482

5 later devices reach Transcom Colon Hydrotherapy Model HC-2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131852HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom20144—
+2K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus20180—
+2K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…Colonplus Equipments & Speculums, S.L.20160—
+2K150381Aqua CleanseQuality Medical Supply, Inc.20151—
+3K201861Bio Fluff SystemGnali Bocia S.R.L.20220—