| Device Type ID | 5645 |
| Device Name | Applier, Staple, Surgical, |
| Regulation Description | Manual Surgical Instrument For General Use. |
| 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 Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GEF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5645 |
| Device | Applier, Staple, Surgical, |
| Product Code | GEF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Activation, Positioning Or Separation Problem | 70 |
Positioning Failure | 36 |
Difficult To Open Or Close | 23 |
Break | 19 |
Sticking | 15 |
Mechanical Jam | 12 |
Device-Device Incompatibility | 8 |
Firing Problem | 8 |
Mechanical Problem | 6 |
Separation Failure | 5 |
Failure To Fire | 5 |
Unknown (for Use When The Device Problem Is Not Known) | 4 |
Activation Problem | 4 |
Premature Activation | 4 |
Detachment Of Device Component | 3 |
Material Separation | 2 |
Detachment Of Device Or Device Component | 2 |
Unintended Ejection | 2 |
Misfire | 2 |
Difficult To Remove | 2 |
Device Operates Differently Than Expected | 2 |
Material Twisted / Bent | 2 |
Material Disintegration | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Material Integrity Problem | 1 |
Failure To Advance | 1 |
Connection Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Delivered As Unsterile Product | 1 |
Melted | 1 |
Loss Of Or Failure To Bond | 1 |
Degraded | 1 |
Deformation Due To Compressive Stress | 1 |
Device Dislodged Or Dislocated | 1 |
Needle | 1 |
Failure To Align | 1 |
Component Falling | 1 |
Entrapment Of Device | 1 |
Failure To Disconnect | 1 |
Physical Resistance / Sticking | 1 |
| Total Device Problems | 255 |