K213274 is an FDA 510(k) clearance for the Qlicksmart BladeFlask UNIVERSAL. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Qlicksmart Pty , Ltd. (Brisbane, AU). The FDA issued a Cleared decision on June 22, 2022, 265 days after receiving the submission on September 30, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K213274 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | June 22, 2022 |
| Days to Decision | 265 days |
| Submission Type | Abbreviated |
| 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 |