Data / Medical devices / Colonic Irrigation System / United States
FDA-registered makers of Colonic Irrigation System in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Colonic Irrigation System (product code KPL). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Colonic Irrigation System
- Product code
- KPL
- Country
- United States
Makers of Colonic Irrigation System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Clearwater Colon Hydrotherapy, Inc. | Ocala, FL, United States | Manufacturer | 2 | August 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Specialty Health Products, LLC. | Phoenix, AZ, United States | Manufacturer | 2 | September 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| Tiller Mind Body, Inc. | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | August 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | July 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | July 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Busse Hospital Disposables | Hauppauge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.