| Device Type ID | 5722 |
| Device Name | Camera, Surgical And Accessories |
| Regulation Description | Surgical Camera 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4160 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KQM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5722 |
| Device | Camera, Surgical And Accessories |
| Product Code | KQM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Camera And Accessories. |
| CFR Regulation Number | 878.4160 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 2 |
Misconnection | 2 |
Inappropriate Shock | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Electrical /Electronic Property Problem | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
No Display / Image | 1 |
Smoking | 1 |
Loss Of Threshold | 1 |
Erratic Or Intermittent Display | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Barco Inc. | II | Nov-05-2015 |
| 2 | Sony Latin America | II | Apr-23-2015 |