# K032584: Rubicor Encapsule Breast Biopsy Device, Model 30629

- Pathway: 510(k) (Special)
- Applicant: Rubicor Medical, Inc.
- Decided: Sep 17, 2003 after 27 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922123 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023601: Rubicor Encapsule Breast Biopsy Device, Model 30086, Rubicor Medical, Inc. (2002)
- K030049: Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086, Rubicor Medical, Inc. (2003) Summary page 1.

## Recalls of this device
- Feb 17, 2006 · Not classified · Z-0715-06: Devices' sterility may be compromised due to lack of adequate sterilization.

## Indications for use
The Encapsule™ 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 Encapsule 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/K032584
Methodology: https://510kreport.com/methodology