| Device Type ID | 5740 |
| Device Name | Clip, Hemostatic |
| Regulation Description | Implantable Clip. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MCH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5740 |
| Device | Clip, Hemostatic |
| Product Code | MCH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Clip. |
| CFR Regulation Number | 878.4300 [🔎] |
| Device Problems | |
|---|---|
Activation, Positioning Or Separation Problem | 105 |
Clip | 57 |
Difficult To Open Or Close | 33 |
Migration Or Expulsion Of Device | 14 |
Break | 12 |
Device Slipped | 5 |
Unintended Movement | 4 |
Material Deformation | 3 |
Premature Activation | 3 |
Detachment Of Device Or Device Component | 3 |
Bushing | 3 |
Device Dislodged Or Dislocated | 3 |
Human-Device Interface Problem | 2 |
Unsealed Device Packaging | 2 |
Material Fragmentation | 1 |
Flaked | 1 |
Defective Device | 1 |
Material Disintegration | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 254 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Applied Medical Resources Corp | II | Apr-05-2016 |