| Device Type ID | 5650 |
| Device Name | Forceps, General & Plastic Surgery |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GEN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5650 |
| Device | Forceps, General & Plastic Surgery |
| Product Code | GEN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 30 |
Tip | 5 |
Detachment Of Device Component | 4 |
Jaw | 3 |
Device Operates Differently Than Expected | 3 |
Device Operational Issue | 2 |
Difficult To Remove | 2 |
Screw | 2 |
Difficult To Open Or Close | 2 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Appropriate Term/Code Not Available | 1 |
Failure To Fold | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Twisted / Bent | 1 |
Bent | 1 |
Fracture | 1 |
Material Integrity Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Insufficient Information | 1 |
Component Falling | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 69 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra York PA, Inc | II | Dec-13-2016 |
| 2 | Micro-Tech (Nanjing) Co., Ltd. | II | Oct-24-2018 |