510(k) K100852
K100852 is an FDA 510(k) premarket notification submitted by Stryker Communications for the device "STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000". The FDA issued a decision of Substantially Equivalent on May 6, 2010. The device falls under product code OCS (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Stryker Communications has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2010
- Date Received
- March 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.