Clearance Summary
BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle received FDA 510(k) clearance under submission number K170386, sponsored by Becton Dickinson & 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 2017-04-12.
- Submission: K170386
- Applicant / Sponsor: Becton Dickinson & Company
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2017-04-12
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.