| Device Type ID | 1676 |
| Device Name | Irrigator, Ostomy |
| Regulation Description | Ostomy Irrigator. |
| 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) Exempt |
| CFR Regulation Number | 876.5895 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EXD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1676 |
| Device | Irrigator, Ostomy |
| Product Code | EXD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ostomy Irrigator. |
| CFR Regulation Number | 876.5895 [🔎] |
| Device Problems | |
|---|---|
Malposition Of Device | 29 |
Device Contamination With Chemical Or Other Material | 2 |
Leak / Splash | 1 |
Material Separation | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 34 |