Clearance Summary
SOL-CARE SAFETY NEEDLE received FDA 510(k) clearance under submission number K123684, sponsored by Sol-Millennium Medical. 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 2013-05-08.
- Submission: K123684
- Applicant / Sponsor: Sol-Millennium Medical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2013-05-08
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.