K180668 is an FDA 510(k) clearance for the Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 15, 2018, 246 days after receiving the submission on March 14, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K180668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2018 |
| Decision Date | November 15, 2018 |
| Days to Decision | 246 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 |