K011270 is an FDA 510(k) clearance for the AUTOMATED CORE BIOPSY DEVICE. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on June 22, 2001, 57 days after receiving the submission on April 26, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K011270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2001 |
| Decision Date | June 22, 2001 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |