| Device Type ID | 1711 |
| Device Name | Rod, Colostomy |
| Regulation Description | Colostomy Rod. |
| 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 | 876.4270 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EZP |
| 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 | 1711 |
| Device | Rod, Colostomy |
| Product Code | EZP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Colostomy Rod. |
| CFR Regulation Number | 876.4270 [🔎] |
| Device Problems | |
|---|---|
Material Fragmentation | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 2 |