Clearance Summary
Howell Biliary Introducer Needle received FDA 510(k) clearance under submission number K160890, sponsored by Wilson-Cook Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2017-06-14.
- Submission: K160890
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2017-06-14
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.