K023923 is an FDA 510(k) clearance for the SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on December 11, 2002, 16 days after receiving the submission on November 25, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K023923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2002 |
| Decision Date | December 11, 2002 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |