510(k) K130423

THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 by Richard Wolf Medical Instruments Corp. — Product Code FET

K130423 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525". The FDA issued a decision of Substantially Equivalent on April 3, 2013. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2013
Date Received
February 20, 2013
Clearance Type
Traditional
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

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.