| Device Type ID | 1919 |
| Device Name | Bag, Drainage, With Adhesive, Ostomy |
| 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 | FON |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1919 |
| Device | Bag, Drainage, With Adhesive, Ostomy |
| Product Code | FON |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ostomy Pouch And Accessories. |
| CFR Regulation Number | 876.5900 [🔎] |
| Device Problems | |
|---|---|
Failure To Adhere Or Bond | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Device Handling Problem | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Use Of Device Problem | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 11 |