K231484 is an FDA 510(k) clearance for the PureWay 1.4 Quart Sharps Collector. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Pureway Compliance, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 14, 2023, 114 days after receiving the submission on May 23, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K231484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2023 |
| Decision Date | September 14, 2023 |
| Days to Decision | 114 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 |