Clearance Summary
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle received FDA 510(k) clearance under submission number K242291, sponsored by Sol-Millennium Medical, Inc.. 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 2024-11-20.
- Submission: K242291
- Applicant / Sponsor: Sol-Millennium Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2024-11-20
Classification & Regulation
This clearance is catalogued under FDA product code QNQ and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.