510(k) K153205
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2016
- Date Received
- November 4, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Central Control Unit
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.