# K023601: Rubicor Encapsule Breast Biopsy Device, Model 30086

- Pathway: 510(k) (Special)
- Applicant: Rubicor Medical, Inc.
- Decided: Nov 19, 2002 after 22 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: 2 generations back to K922123 (1993). 4 ancestors in all.
4 later devices descend from it; 3 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)
- K020047: Rubicor Breast Biopsy Device, Rubicor Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K030049: Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086 (2003), 3 descendants of its own
- 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 procedure. The Rubicor EncapsuleTMBreast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

Source page: https://510kreport.com/device/K023601
Methodology: https://510kreport.com/methodology