K250733 is an FDA 510(k) clearance for the 3DOSE 1ml Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Bimed Teknik Aletler Sanayi & Ticaret A.S. (Istanbul, TR). The FDA issued a Cleared decision on July 3, 2025, 114 days after receiving the submission on March 11, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K250733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2025 |
| Decision Date | July 03, 2025 |
| Days to Decision | 114 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 |