K222852 is an FDA 510(k) clearance for the Nipro SafeTouch Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on May 25, 2023, 246 days after receiving the submission on September 21, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K222852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2022 |
| Decision Date | May 25, 2023 |
| Days to Decision | 246 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 |