Clearance Summary
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe received FDA 510(k) clearance under submission number K253110, 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 2026-06-18.
- Submission: K253110
- 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: 2026-06-18
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.