K243806 is an FDA 510(k) clearance for the Safety Winged Blood Collection Sets. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on January 10, 2025, 30 days after receiving the submission on December 11, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K243806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |