Cleared Traditional

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · General Hospital
Dec 2025
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K253222 is an FDA 510(k) clearance for the Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G), a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Zhejiang Gongdong Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on December 22, 2025, 84 days after receiving the submission on September 29, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K253222 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date December 22, 2025
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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