| Device Type ID | 5535 |
| Device Name | Camera, Television, Surgical, Without Audio |
| 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 | FWB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5535 |
| Device | Camera, Television, Surgical, Without Audio |
| Product Code | FWB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Camera And Accessories. |
| CFR Regulation Number | 878.4160 [🔎] |
| Device Problems | |
|---|---|
Device Emits Odor | 1 |
Break | 1 |
Device Inoperable | 1 |
Power Supply | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sony Medical Systems | II | Sep-16-2015 |
| 2 | Trumpf Medical Systems, Inc. | II | Mar-01-2018 |