K180363 is an FDA 510(k) clearance for the Clear-Tip EUS-FNA. 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 November 1, 2018, 265 days after receiving the submission on February 9, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K180363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2018 |
| Decision Date | November 01, 2018 |
| Days to Decision | 265 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 |