Clearance Summary
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y received FDA 510(k) clearance under submission number K981683, sponsored by Venusa , Ltd.. 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 1998-07-28.
- Submission: K981683
- Applicant / Sponsor: Venusa , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1998-07-28
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.