K032847 is an FDA 510(k) clearance for the EXCISOR BIOPTOME, MODEL 01-0004, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Acueity, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 26, 2003, 14 days after receiving the submission on September 12, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K032847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2003 |
| Decision Date | September 26, 2003 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1075 |