K241209 is an FDA 510(k) clearance for the EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19). This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on July 29, 2024, 90 days after receiving the submission on April 30, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K241209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2024 |
| Decision Date | July 29, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |