Clearance Summary
Regular and Special Umbilical Cord Clamp and Cutter received FDA 510(k) clearance under submission number K152350, sponsored by Ningbo Feite Medical Device Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2016-06-28.
- Submission: K152350
- Applicant / Sponsor: Ningbo Feite Medical Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2016-06-28
Classification & Regulation
This clearance is catalogued under FDA product code NBZ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.