Clearance Summary
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe received FDA 510(k) clearance under submission number K161552, sponsored by Becton, Dickinson and Company. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-02-02.
- Submission: K161552
- Applicant / Sponsor: Becton, Dickinson and Company
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2017-02-02
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.