Clearance Summary
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE received FDA 510(k) clearance under submission number K111895, sponsored by Wilson-Cook Medical Inc./Cook Endoscopy. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-04-27.
- Submission: K111895
- Applicant / Sponsor: Wilson-Cook Medical Inc./Cook Endoscopy
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2012-04-27
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.