510(k) K253222

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) by Zhejiang Gongdong Medical Technology Co., Ltd. — Product Code MMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2025
Date Received
September 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type