K150263 is an FDA 510(k) clearance for the K-Pack II Needle-21G x 2. 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 April 1, 2015, 56 days after receiving the submission on February 4, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K150263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2015 |
| Decision Date | April 01, 2015 |
| Days to Decision | 56 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 |