Clearance Summary
WTF SECURA SYRINGE AND NEEDLE received FDA 510(k) clearance under submission number K132120, sponsored by Beijing Wantefu Medical Apparatus 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 2013-12-12.
- Submission: K132120
- Applicant / Sponsor: Beijing Wantefu Medical Apparatus Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2013-12-12
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.