Panels › Gastroenterology, Urology › Product code KPL · Class 2
Colonic Irrigation System
Regulation 876.5220
0510(k)s in 12 months (40 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in KPL
| Company | 510(k)s | Recalls |
|---|---|---|
| Colon Therapeutics | 8 | 0 |
| Tiller Mind Body, Inc. | 3 | 0 |
| Clearwater Colon Hydrotherapy, Inc. | 2 | 0 |
| Edermy LLC | 0 | 2 |
| Gentle Colonics, Inc. | 2 | 0 |
| Prime Pacific Health Innovations Corporation | 2 | 0 |
| Ultimate Concepts, Inc. | 2 | 0 |
| 3M Health Care, Sarns | 1 | 0 |
| Atlantic Health Group | 1 | 0 |
| Clearwater Products, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2026 | Edermy LLC PIE PAK
Models: P2HC-A, P2HC-S, P2HC Open, Classified |
KPL | None listed |
| Feb 24, 2026 | Edermy LLC PIE Trolley System
Model: 2005 Open, Classified |
KPL | None listed |
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