K250994 is an FDA 510(k) clearance for the ClearTip FNA and FNB Types. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Finemedix Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 21, 2025, 142 days after receiving the submission on April 1, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K250994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2025 |
| Decision Date | August 21, 2025 |
| Days to Decision | 142 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 |