Clearance Summary
ECHO TIP ULTRA FIDUCIAL NEEDLE received FDA 510(k) clearance under submission number K141356, sponsored by Wilson-Cook Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2014-06-20.
- Submission: K141356
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2014-06-20
Classification & Regulation
This clearance is catalogued under FDA product code NEU and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.