K040266 is an FDA 510(k) clearance for the CORE NEEDLE BIOPSY. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 9, 2004, 155 days after receiving the submission on February 5, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K040266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2004 |
| Decision Date | July 09, 2004 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |