Clearance Summary
EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) received FDA 510(k) clearance under submission number K230909, sponsored by Cook Ireland, Ltd.. 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 2023-05-30.
- Submission: K230909
- Applicant / Sponsor: Cook Ireland, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2023-05-30
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.