Clearance Summary
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle received FDA 510(k) clearance under submission number K162030, sponsored by Sol-Millennium Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-08-19.
- Submission: K162030
- Applicant / Sponsor: Sol-Millennium Medical, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2016-08-19
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.