K180233 is an FDA 510(k) clearance for the Eviva Stereotactic Guided Breast Biopsy System. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on April 10, 2018, 71 days after receiving the submission on January 29, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K180233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2018 |
| Decision Date | April 10, 2018 |
| Days to Decision | 71 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 |