# K051581: Sanarus Cassi II Rotational Core Biopsy System, Model CS2000

- Pathway: 510(k) (Traditional)
- Applicant: Sanarus Medical, Inc.
- Decided: Jul 27, 2005 after 42 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: 5 generations back to K003528 (2001). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042136: Sanarus Cassi Rotational Core Biopsy System, Sanarus Medical, Inc. (2004) Summary page 2.

## Most influential descendants
- K123606: Cassi II Rotational Core Biopsy System; Cassi Quadpoint Disposable (2013), 1 descendant of its own
- K173316: SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device (2018), 0 descendants of its own
- K161234: CASSI II Rotational Core Biopsy System (2016), 0 descendants of its own
- K080171: Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012 (2008), 0 descendants of its own

## Indications for use
The 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 device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 a 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 procedures.

Source page: https://510kreport.com/device/K051581
Methodology: https://510kreport.com/methodology