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Colonic Irrigation System
FDA product code KPL · Class 2 · Gastroenterology, Urology
31
Registered devices
16
Adverse events
2
Recalls
40
510(k) clearances
Devices with this code
Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Aquanet — Prime Pacific Health Innovations CorporationColonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC.QMS - AQUA CLEANSE — QUALITY MEDICAL SUPPLY, INC.Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SLColonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC.Colonic irrigation Kit — TRANSCENDENCIAS COMERCIALES SLColonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC.Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SLColonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Angel of Water — LIFESTREAM PURIFICATION SYSTEM LLCColonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Aquanet — Prime Pacific Health Innovations CorporationColonic Irrigation Kit — TRANSCENDENCIAS COMERCIALES SLLIBBE Colon Hydrotherapy System — Mind Body Naturopathic InstAquanet — Prime Pacific Health Innovations CorporationColonic Irrigation Kit — TRANSCENDENCIAS COMERCIALES SLColon Cleansing Nozzle with Flex Tube — LIFESTREAM PURIFICATION SYSTEM LLCColonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.Colonic Irrigation Kit — TRANSCENDENCIAS COMERCIALES SLColonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-14 | Edermy LLC | Lack of 510K clearance |
| 2026-01-14 | Edermy LLC | Lack of 510K clearance |
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