| Device Type ID | 5728 |
| Device Name | Scissors, General, 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) 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 | LRW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5728 |
| Device | Scissors, General, Surgical |
| Product Code | LRW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 42 |
Delivered As Unsterile Product | 8 |
Contamination / Decontamination Problem | 8 |
Fracture | 6 |
Material Fragmentation | 6 |
Material Integrity Problem | 5 |
Material Separation | 4 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Inadequate Service | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Fire | 1 |
Device Maintenance Issue | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Loose Or Intermittent Connection | 1 |
Device Disinfection Or Sterilization Issue | 1 |
| Total Device Problems | 92 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra York PA, Inc | II | Dec-13-2016 |
| 2 | Teleflex Medical Europe Ltd | II | Jun-14-2018 |