Clearance Summary
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE received FDA 510(k) clearance under submission number K121050, sponsored by Becton, Dickinson & CO. 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 2013-02-07.
- Submission: K121050
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2013-02-07
Classification & Regulation
This clearance is catalogued under FDA product code NGT and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.