| Device Type ID | 5539 |
| Device Name | Camera, Television, Endoscopic, 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 | FWF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5539 |
| Device | Camera, Television, Endoscopic, Without Audio |
| Product Code | FWF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Camera And Accessories. |
| CFR Regulation Number | 878.4160 [🔎] |
| Device Problems | |
|---|---|
Intermittent Loss Of Power | 5 |
Failure To Power Up | 4 |
Intermittent Continuity | 2 |
Optical Distortion | 1 |
Intermittent Energy Output | 1 |
Device Stops Intermittently | 1 |
Device Operates Differently Than Expected | 1 |
Operating System Becomes Nonfunctional | 1 |
Computer Operating System Problem | 1 |
Unexpected Shutdown | 1 |
Image Display Error / Artifact | 1 |
Poor Quality Image | 1 |
Computer Software Problem | 1 |
Loose Or Intermittent Connection | 1 |
| Total Device Problems | 22 |