K203211 is an FDA 510(k) clearance for the Insulin syringe with integrated needle DL. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Dlp Medical Products, Corp. (San Antonio, US). The FDA issued a Cleared decision on February 9, 2023, 832 days after receiving the submission on October 30, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K203211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2020 |
| Decision Date | February 09, 2023 |
| Days to Decision | 832 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |