K230070 is an FDA 510(k) clearance for the MESORAM® Hypodermic Needle (710301). This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Promamedical, Inc. (Miami, US). The FDA issued a Cleared decision on October 5, 2023, 268 days after receiving the submission on January 10, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K230070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2023 |
| Decision Date | October 05, 2023 |
| Days to Decision | 268 days |
| Submission Type | Abbreviated |
| 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 |