K052474 is an FDA 510(k) clearance for the NIPRO HYPODERMIC NEEDLE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Nipro Medical Corp. (Lexington, US). The FDA issued a Cleared decision on November 10, 2005, 62 days after receiving the submission on September 9, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K052474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2005 |
| Decision Date | November 10, 2005 |
| Days to Decision | 62 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 |