Clearance Summary
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 received FDA 510(k) clearance under submission number K063450, sponsored by Smiths Medical Asd, Inc.. 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 2007-01-25.
- Submission: K063450
- Applicant / Sponsor: Smiths Medical Asd, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2007-01-25
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.