510(k) K200481

Andorate Biopsy Valve, Andorate Biopsy Irrigator by Ga Health Company Limited — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2020
Date Received
February 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.