| Device Type ID | 5507 |
| Device Name | Table, Operating-room, Ac-powered |
| 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 | FQO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5507 |
| Device | Table, Operating-room, Ac-powered |
| Product Code | FQO |
| 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 | |
|---|---|
Device Operates Differently Than Expected | 16 |
Use Of Device Problem | 12 |
Unintended Movement | 12 |
Detachment Of Device Component | 6 |
Device Handling Problem | 6 |
Mechanical Problem | 4 |
Device Dislodged Or Dislocated | 4 |
Device Inoperable | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Material Integrity Problem | 3 |
Electrical /Electronic Property Problem | 3 |
Device Displays Incorrect Message | 3 |
Break | 3 |
Positioning Problem | 3 |
Impedance Problem | 2 |
Insufficient Information | 2 |
Material Separation | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Unintended System Motion | 2 |
Fracture | 2 |
Table | 1 |
Self-Activation Or Keying | 1 |
Circuit Failure | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Leak / Splash | 1 |
Device Maintenance Issue | 1 |
Unintended Collision | 1 |
Material Deformation | 1 |
Noise, Audible | 1 |
Fluid Leak | 1 |
Unintended Head Motion | 1 |
Detachment Of Device Or Device Component | 1 |
Component Falling | 1 |
| Total Device Problems | 108 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Berchtold Corp. | II | Oct-22-2015 |
| 2 | Deerfield Imaging, Inc. | II | Dec-20-2018 |
| 3 | Deerfield Imaging, Inc. | II | Mar-28-2018 |
| 4 | Deerfield Imaging, Inc. | II | Mar-27-2018 |
| 5 | Deerfield Imaging, Inc. | II | Mar-13-2018 |
| 6 | IMRIS Inc | II | Oct-28-2014 |
| 7 | Maquet Cardiovascular Us Sales, Llc | II | Sep-07-2016 |
| 8 | Maquet Cardiovascular Us Sales, Llc | II | Mar-03-2016 |
| 9 | Maquet Cardiovascular Us Sales, Llc | II | Jul-17-2015 |
| 10 | Maquet Medical Systems USA | II | Nov-10-2016 |
| 11 | Skytron, Div. The KMW Group, Inc | II | May-31-2016 |
| 12 | Skytron, Div. The KMW Group, Inc | II | Jan-14-2016 |
| 13 | Steris Corporation | II | Jul-09-2014 |