Clearance Summary
Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use received FDA 510(k) clearance under submission number K201284, sponsored by Set Medikal Sanayi VE Ticaret Anonim Sirketi. 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 2020-12-14.
- Submission: K201284
- Applicant / Sponsor: Set Medikal Sanayi VE Ticaret Anonim Sirketi
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2020-12-14
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.