| Device Type ID | 5714 |
| Device Name | Bag, Intestine |
| Regulation Description | Organ Bag. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KGY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5714 |
| Device | Bag, Intestine |
| Product Code | KGY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Organ Bag. |
| CFR Regulation Number | 878.4100 [🔎] |
| Device Problems | |
|---|---|
Break | 3 |
Torn Material | 2 |
Burst Container Or Vessel | 2 |
Material Disintegration | 1 |
Difficult To Remove | 1 |
Bent | 1 |
Material Integrity Problem | 1 |
Split | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Jun-24-2015 |