K253222 is an FDA 510(k) clearance for the Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G). This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K253222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MMK - Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |