# K161234: CASSI II Rotational Core Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Scion Medical Technologies, LLC
- Decided: Aug 3, 2016 after 93 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: 7 generations back to K003528 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123606: Cassi II Rotational Core Biopsy System; Cassi Quadpoint Disposable, Scion Medical Technologies, LLC (2013) Summary page 4.

## Indications for use
The Cassi Rotational Core Biopsy Device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. It is not intended for use in bone. The Cassi Device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of a histological 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 a histological 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 procedures.

Source page: https://510kreport.com/device/K161234
Methodology: https://510kreport.com/methodology