K211890 is an FDA 510(k) clearance for the Promisemed Sharps container. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on November 17, 2021, 149 days after receiving the submission on June 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K211890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | November 17, 2021 |
| Days to Decision | 149 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 |