Clearance Summary
SURE-WAY REUSABLE SHARPS CONTAINER received FDA 510(k) clearance under submission number K992626, sponsored by Sure-Way Systems, 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 1999-12-16.
- Submission: K992626
- Applicant / Sponsor: Sure-Way Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1999-12-16
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.