# K021137: Sanarus Centrica Core Tissue Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Sanarus Medical, Inc.
- Decided: Jun 26, 2002 after 78 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 K003528 (2001). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003528: Sanarus Core Tissue Biopsy System, Endocare, Inc. (2001). Our reading of the summary gave K013528, FDA’s number for Crystal 5000 Phases Array TMJ Coil (Usa Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sanarus Core Tissue Biopsy System”.

## Most influential descendants
- K022879: Modification to Sanarus Centrica Core Tissue Biopsy (2002), 10 descendants of its own
- K032506: Sanarus Centrica II Rotational Core Biopsy System (2003), 9 descendants of its own
- K042136: Sanarus Cassi Rotational Core Biopsy System (2004), 8 descendants of its own
- K051581: Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 (2005), 4 descendants of its own
- K053151: Rubicor Magic Breast Biopsy Device (2005), 3 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/K021137
Methodology: https://510kreport.com/methodology