Definition: To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
| Device Type ID | 2060 |
| Device Name | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Physical State | May Include: Ccd Camera, Monitor, Other Software Or Hardware Associated With Video Equipment, And Components From Other Regulations, Such As A Pump. |
| Technical Method | Inserted Through Endoscope |
| Target Area | Various Body Cavities, Hollow Organs, And Canals In GI And GU Tract |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2060 |
| Device | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Product Code | OCS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Olympus Corporation Of The Americas | II | Jul-20-2018 |