Clearance Summary
SHARPTRACK REUSABLE SHARPS CONTAINER received FDA 510(k) clearance under submission number K981184, sponsored by Bfi- Medical Waste Systems. 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 1998-06-22.
- Submission: K981184
- Applicant / Sponsor: Bfi- Medical Waste Systems
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1998-06-22
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.