K230909 is an FDA 510(k) clearance for the EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22). 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 May 30, 2023, 60 days after receiving the submission on March 31, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K230909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2023 |
| Decision Date | May 30, 2023 |
| Days to Decision | 60 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 |