K100436 is an FDA 510(k) clearance for the CLICKFINE PEN NEEDLE. 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 April 30, 2010, 73 days after receiving the submission on February 16, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K100436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2010 |
| Decision Date | April 30, 2010 |
| Days to Decision | 73 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 |