K241209
- 510(k) number
- K241209
- Device name
- EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- Applicant
- Cook Ireland, Ltd. IE
- Product code
- FCG — Biopsy Needle
- Decision date
- 2024-07-29
- Date received
- 2024-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K241209.pdf
Official FDA record: K241209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.