| Device Type ID | 1680 |
| Device Name | Bag, Urinary, Ileostomy |
| Regulation Description | Ostomy Pouch And Accessories. |
| 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 | 876.5900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EXH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1680 |
| Device | Bag, Urinary, Ileostomy |
| Product Code | EXH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ostomy Pouch And Accessories. |
| CFR Regulation Number | 876.5900 [🔎] |
| Device Problems | |
|---|---|
Malposition Of Device | 124 |
Adverse Event Without Identified Device Or Use Problem | 40 |
Occlusion Within Device | 22 |
Appropriate Term/Code Not Available | 11 |
Human-Device Interface Problem | 9 |
No Flow | 8 |
Deflation Problem | 7 |
Difficult To Remove | 4 |
Device Operates Differently Than Expected | 4 |
Fluid Leak | 3 |
Leak / Splash | 3 |
Blocked Connection | 2 |
Increased Sensitivity | 2 |
Connection Problem | 2 |
Use Of Device Problem | 1 |
Delamination | 1 |
Loss Of Or Failure To Bond | 1 |
Failure To Adhere Or Bond | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Break | 1 |
Defective Device | 1 |
Reflux Within Device | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Separation | 1 |
| Total Device Problems | 253 |