| Device Type ID | 5707 |
| Device Name | Instrument, Surgical, Disposable |
| 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) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KDC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5707 |
| Device | Instrument, Surgical, Disposable |
| Product Code | KDC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 59 |
Break | 13 |
Device Packaging Compromised | 7 |
Device Contamination With Chemical Or Other Material | 3 |
Fracture | 3 |
Detachment Of Device Component | 2 |
Material Separation | 2 |
Device Contaminated During Manufacture Or Shipping | 1 |
Split | 1 |
Defective Device | 1 |
Packaging Problem | 1 |
Torn Material | 1 |
Component Falling | 1 |
Migration Or Expulsion Of Device | 1 |
Defective Component | 1 |
Migration | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 99 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ethicon, Inc. | II | Sep-27-2016 |