K222906 is an FDA 510(k) clearance for the Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Ningbo Maxcon Medical Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on June 16, 2023, 266 days after receiving the submission on September 23, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K222906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 266 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 |