Clearance Summary
3DOSE 1ml Syringe received FDA 510(k) clearance under submission number K250733, sponsored by Bimed Teknik Aletler Sanayi & Ticaret A.S.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-07-03.
- Submission: K250733
- Applicant / Sponsor: Bimed Teknik Aletler Sanayi & Ticaret A.S.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2025-07-03
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.