K110105 is an FDA 510(k) clearance for the BD PEN NEEDLE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Becton, Dickinson and Company (BD) (Franklin Lakes, US). The FDA issued a Cleared decision on April 28, 2011, 105 days after receiving the submission on January 13, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K110105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2011 |
| Decision Date | April 28, 2011 |
| Days to Decision | 105 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 |