K231907 is an FDA 510(k) clearance for the Medline Safety Insulin and TB Syringes. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on October 18, 2023, 111 days after receiving the submission on June 29, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K231907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2023 |
| Decision Date | October 18, 2023 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG — Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |