Clearance Summary
ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT received FDA 510(k) clearance under submission number K023098, sponsored by Mckinley Infuser. 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 2002-12-09.
- Submission: K023098
- Applicant / Sponsor: Mckinley Infuser
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2002-12-09
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.