K211634 is an FDA 510(k) clearance for the Hypodermic Needle-Pro EDGE Safety Device. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 26, 2021, 91 days after receiving the submission on May 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K211634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2021 |
| Decision Date | August 26, 2021 |
| Days to Decision | 91 days |
| Submission Type | Special |
| 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 |