# K180233: Eviva Stereotactic Guided Breast Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Apr 10, 2018 after 71 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042290 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042290: Vacuum Assisted Core Biopsy Device, Suros Surgical Systems, Inc. (2004) Summary page 4.

## Indications for use
The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

Source page: https://510kreport.com/device/K180233
Methodology: https://510kreport.com/methodology