K201523 is an FDA 510(k) clearance for the Sharps container. 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 November 12, 2020, 157 days after receiving the submission on June 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K201523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2020 |
| Decision Date | November 12, 2020 |
| Days to Decision | 157 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 |