510(k) K153205
K153205 is an FDA 510(k) premarket notification submitted by Black Diamond Video, Inc. for the device "IDSS ForceTriad Control Module". The FDA issued a decision of Substantially Equivalent on August 1, 2016. The device falls under product code ODA (Endoscopic Central Control Unit), a Class II device regulated under 21 CFR 876.1500. Black Diamond Video, Inc. has at least 1 other 510(k) clearance on record.
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.