K994272 is an FDA 510(k) clearance for the AUTOMATED CORE BIOPSY DEVICE, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on January 7, 2000, 18 days after receiving the submission on December 20, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K994272 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1999 |
| Decision Date | January 07, 2000 |
| Days to Decision | 18 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 |