# K003528: Sanarus Core Tissue Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: May 3, 2001 after 168 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021137: Sanarus Centrica Core Tissue Biopsy System (2002), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K003528
Methodology: https://510kreport.com/methodology