K113469 is an FDA 510(k) clearance for the NIPRO HUBER INFUSION, EXCEL HUBER 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 October 18, 2012, 331 days after receiving the submission on November 22, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K113469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2011 |
| Decision Date | October 18, 2012 |
| Days to Decision | 331 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 |