K151398 is an FDA 510(k) clearance for the K-Pack II Needle - 29G x 5/16 Thin Wall. This device is classified as 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 June 25, 2015, 30 days after receiving the submission on May 26, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K151398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2015 |
| Decision Date | June 25, 2015 |
| Days to Decision | 30 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 |