K212095 is an FDA 510(k) clearance for the SurGuard3 Safety Hypodermic Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on August 22, 2022, 412 days after receiving the submission on July 6, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K212095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2021 |
| Decision Date | August 22, 2022 |
| Days to Decision | 412 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 |