510(k) K212808

Logic Hd camera head green, System green by Richard Wolf Medical Instruments Corporation — Product Code FET

K212808 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corporation for the device "Logic Hd camera head green, System green". The FDA issued a decision of Substantially Equivalent on June 14, 2022. 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 Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2022
Date Received
September 3, 2021
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.