510(k) K172817
K172817 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA". The FDA issued a decision of Substantially Equivalent on Oct 17, 2017. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2017
- Date Received
- Sep 18, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.