Clearance Summary
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE received FDA 510(k) clearance under submission number K073122, sponsored by Covidien Lp, Formerly Registered AS Tyco Healthcar. 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 2007-11-21.
- Submission: K073122
- Applicant / Sponsor: Covidien Lp, Formerly Registered AS Tyco Healthcar
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2007-11-21
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.