| Device Type ID | 5625 |
| Device Name | Table, Operating-room, Electrical |
| Regulation Description | Operating Tables And Accessories And Operating Chairs And Accessories. |
| 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 | 878.4960 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5625 |
| Device | Table, Operating-room, Electrical |
| Product Code | GDC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Operating Tables And Accessories And Operating Chairs And Accessories. |
| CFR Regulation Number | 878.4960 [🔎] |
| Device Problems | |
|---|---|
Unintended Movement | 187 |
Mechanical Problem | 13 |
Detachment Of Device Component | 11 |
Use Of Device Problem | 8 |
Improper Or Incorrect Procedure Or Method | 7 |
Device Operates Differently Than Expected | 6 |
Inadequate Service | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Maintenance Does Not Comply To Manufacturers Recommendations | 3 |
Device Maintenance Issue | 3 |
Insufficient Information | 2 |
Switch, Push Button | 2 |
Failure To Service | 2 |
Unstable | 1 |
Material Integrity Problem | 1 |
Human-Device Interface Problem | 1 |
Fire | 1 |
Smoking | 1 |
Device Dislodged Or Dislocated | 1 |
Material Frayed | 1 |
Component Falling | 1 |
Loose Or Intermittent Connection | 1 |
Low Battery | 1 |
Positioning Problem | 1 |
Unintended Head Motion | 1 |
Detachment Of Device Or Device Component | 1 |
Unintended Collision | 1 |
Off-Label Use | 1 |
Inadequate Or Insufficient Training | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 268 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Mizuho OSI | II | Feb-09-2016 |
| 2 | Skytron, Div. The KMW Group, Inc | II | May-31-2016 |
| 3 | Steris Corporation | II | Nov-07-2014 |