Clearance Summary
GO MEDICAL BALLOON INFUSION SYSTEM received FDA 510(k) clearance under submission number K000263, sponsored by Go Medical Industries Pty. , 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 2000-05-09.
- Submission: K000263
- Applicant / Sponsor: Go Medical Industries Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2000-05-09
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.