Definition: To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.
| Device Type ID | 2068 |
| Device Name | Endoscopic Central Control Unit |
| Physical State | May Include: Monitor, Remote (or Other Wireless Device), Microphone, Card Adaptor, Cables, Other Hardware And Software |
| Technical Method | Connect Operating Systems Into Central Control Unit |
| Target Area | Endoscopic And Other Ancillary Surgical Equipment |
| 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 | ODA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2068 |
| Device | Endoscopic Central Control Unit |
| Product Code | ODA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RICHARD WOLF | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RICHARD WOLF GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Erratic Or Intermittent Display | 1 |
Insufficient Information | 1 |
| Total Device Problems | 2 |