# K053151: Rubicor Magic Breast Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Rubicor Medical, Inc.
- Decided: Nov 18, 2005 after 8 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). 10 ancestors in all.
3 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)
- K991980: Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch,, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K042136: Sanarus Cassi Rotational Core Biopsy System, Sanarus Medical, Inc. (2004) Summary page 1.
- K024089: Vacuflash Biopsy System, Bip USA, Inc. (2003) Summary page 1.

## Most influential descendants
- K071048: Rubicor Magic Breast Biopsy Device, Model 31537 (2007), 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
- K133702: Presto Breast Biopsy Device (2014), 0 descendants of its own

## Indications for use
The Rubicor Magic TM Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. The Rubicor Magic TM Breast Biopsy Device is 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/K053151
Methodology: https://510kreport.com/methodology