K232165 is an FDA 510(k) clearance for the Sterile Safety Hypodermic Needles for Single Use. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Berpu Medical Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on February 1, 2024, 195 days after receiving the submission on July 21, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K232165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2023 |
| Decision Date | February 01, 2024 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| 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 |