K150662 is an FDA 510(k) clearance for the Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated). This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on June 9, 2015, 88 days after receiving the submission on March 13, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K150662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2015 |
| Decision Date | June 09, 2015 |
| Days to Decision | 88 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 |