K050120 is an FDA 510(k) clearance for the EASY CORE BIOPSY SYSTEM II. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on February 8, 2005, 21 days after receiving the submission on January 18, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K050120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2005 |
| Decision Date | February 08, 2005 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |