| Device Type ID | 1972 |
| Device Name | Colonic Irrigation System |
| Regulation Description | Colonic Irrigation System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1972 |
| Device | Colonic Irrigation System |
| Product Code | KPL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Colonic Irrigation System. |
| CFR Regulation Number | 876.5220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COLONIC PLUS | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
QUALITY MEDICAL SUPPLY INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRANSCENDENCIAS COMERCIALES SL TRANSCOM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Issue | 1 |
Missing Value Reason | 1 |
| Total Device Problems | 2 |