Submission Details
| 510(k) Number | K212095 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SurGuard3 Safety Hypodermic Needle
Aug 2022
Decision
412d
Days
Class 2
Risk
About This 510(k) Submission
K212095 is an FDA 510(k) clearance for the SurGuard3 Safety Hypodermic Needle, 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 review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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