# K030049: Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086

- Pathway: 510(k) (Special)
- Applicant: Rubicor Medical, Inc.
- Decided: Jan 29, 2003 after 23 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: 3 generations back to K922123 (1993). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 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)

## Most influential descendants
- K052506: Rubicor Encapsule Breast Biopsy Device, Model 31108 (2005), 1 descendant of its own
- K070275: Flexible Loop Electrosurgical Electrode (2007), 0 descendants of its own
- K032584: Rubicor Encapsule Breast Biopsy Device, Model 30629 (2003), 0 descendants of its own

## 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 Rubicor EncapsuleTMBreast 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 EncapsuleTMBreast 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 a partial or complete removal of the imaged abnormality . The extent of histological abnormality cannot be reliably determined from its inammographic 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 abnoiinality 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/K030049
Methodology: https://510kreport.com/methodology