K192677 is an FDA 510(k) clearance for the Safety Insulin Pen Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on February 18, 2020, 145 days after receiving the submission on September 26, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K192677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2019 |
| Decision Date | February 18, 2020 |
| Days to Decision | 145 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 |