Clearance Summary
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) received FDA 510(k) clearance under submission number K243149, sponsored by Congruence Medical Solutions, LLC. 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 2024-12-20.
- Submission: K243149
- Applicant / Sponsor: Congruence Medical Solutions, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2024-12-20
Classification & Regulation
This clearance is catalogued under FDA product code QLY and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.