| Device Type ID | 5676 |
| Device Name | Pliers, 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 | HTC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5676 |
| Device | Pliers, Surgical |
| Product Code | HTC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 70 |
Material Fragmentation | 13 |
Fitting Problem | 9 |
Device Operates Differently Than Expected | 8 |
Component Missing | 7 |
Detachment Of Device Or Device Component | 5 |
Device Or Device Fragments Location Unknown | 3 |
Material Twisted / Bent | 3 |
Bent | 2 |
Device Dislodged Or Dislocated | 2 |
Device Difficult To Maintain | 2 |
Device-Device Incompatibility | 2 |
Material Deformation | 2 |
Detachment Of Device Component | 1 |
Material Separation | 1 |
Mechanical Jam | 1 |
Naturally Worn | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Component Falling | 1 |
Dull, Blunt | 1 |
Difficult To Open Or Close | 1 |
Device Reprocessing Problem | 1 |
Fracture | 1 |
Device Operational Issue | 1 |
Device Inoperable | 1 |
| Total Device Problems | 142 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Jan-07-2015 |
| 2 | The Anspach Effort, Inc. | II | Feb-03-2016 |