# K042290: Vacuum Assisted Core Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Suros Surgical Systems, Inc.
- Decided: Oct 6, 2004 after 43 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K163052: Brevera Biopsy System with Corlumina Imaging Technology (2017), 1 descendant of its own
- K262792: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) (2026), 0 descendants of its own
- K180233: Eviva Stereotactic Guided Breast Biopsy System (2018), 0 descendants of its own

## Recalls of this device
- Aug 11, 2010 · Not classified · Z-2285-2010: The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20.
- Feb 1, 2010 · Not classified · Z-1160-2010: The product is labeled as ATEC0909-12 but it actually contains 0909-20.
- Sep 22, 2008 · Not classified · Z-0275-2009: The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.
- Dec 15, 2006 · Not classified · Z-0362-2007: The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

## Indications for use
The ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System 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 manmographic appearance. Therefore, the extent of removal of the imaged evidence of an abnorninality does not predict theextent of removal ofhistologic abnormality, e.g., malignancy. Wh'/en 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/K042290
Methodology: https://510kreport.com/methodology