Clearance Summary
I-PORT ADVANCE INJECTION PORT received FDA 510(k) clearance under submission number K120337, sponsored by Unomedical A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-02-16.
- Submission: K120337
- Applicant / Sponsor: Unomedical A/S
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2012-02-16
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.