Clearance Summary
Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe received FDA 510(k) clearance under submission number K232943, sponsored by Smiths Medical Asd, Inc.. 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 2024-05-31.
- Submission: K232943
- Applicant / Sponsor: Smiths Medical Asd, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2024-05-31
Classification & Regulation
This clearance is catalogued under FDA product code QNQ and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.