K211716 is an FDA 510(k) clearance for the DropSafe Safety Pen Needles. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Htl Strefa SA (Ozorków, PL). The FDA issued a Cleared decision on January 7, 2022, 218 days after receiving the submission on June 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K211716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| 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 |