K041399 is an FDA 510(k) clearance for the HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on July 28, 2004, 63 days after receiving the submission on May 26, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K041399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2004 |
| Decision Date | July 28, 2004 |
| Days to Decision | 63 days |
| Submission Type | Abbreviated |
| 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 |