K203792 is an FDA 510(k) clearance for the Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Pikdare Spa (Casnate Con Bernate, IT). The FDA issued a Cleared decision on January 20, 2023, 753 days after receiving the submission on December 28, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K203792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2020 |
| Decision Date | January 20, 2023 |
| Days to Decision | 753 days |
| Submission Type | Abbreviated |
| 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 |