Clearance Summary
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER received FDA 510(k) clearance under submission number K000665, sponsored by Tfx Medical, 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 2000-05-02.
- Submission: K000665
- Applicant / Sponsor: Tfx Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2000-05-02
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.