Clearance Summary
INSULIN PEN NEEDLE received FDA 510(k) clearance under submission number K133058, sponsored by Wenzhou Wuzhou Import & Export Co., Ltd.. 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 2014-02-25.
- Submission: K133058
- Applicant / Sponsor: Wenzhou Wuzhou Import & Export Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2014-02-25
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.