| Device Type ID | 2608 |
| Device Name | Binder, Abdominal |
| Regulation Description | Therapeutic Medical Binder. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5160 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FSD |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2608 |
| Device | Binder, Abdominal |
| Product Code | FSD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Therapeutic Medical Binder. |
| CFR Regulation Number | 880.5160 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Insufficient Information | 4 |
Stretched | 1 |
Material Distortion | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Frayed | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 14 |