510(k) K201509

Disposable Stone Extraction basket by Hangzhou AGS MedTech Co., Ltd. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2020
Date Received
June 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type