Clearance Summary
Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen received FDA 510(k) clearance under submission number K213146, sponsored by Jiangsu Rongye Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2023-10-27.
- Submission: K213146
- Applicant / Sponsor: Jiangsu Rongye Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2023-10-27
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.