K193422 is an FDA 510(k) clearance for the Easydrip Pen Needle, Easydrip Plus Pen Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Sandstone Medical (Suzhou), Inc. (Suzhou, CN). The FDA issued a Cleared decision on February 2, 2021, 421 days after receiving the submission on December 9, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K193422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2019 |
| Decision Date | February 02, 2021 |
| Days to Decision | 421 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 |