K150333 is an FDA 510(k) clearance for the MedSource Sharps Dart. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Medsource International, LLC (Chaska, US). The FDA issued a Cleared decision on May 8, 2015, 87 days after receiving the submission on February 10, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K150333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2015 |
| Decision Date | May 08, 2015 |
| Days to Decision | 87 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 |