# K020047: Rubicor Breast Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Rubicor Medical, Inc.
- Decided: Apr 5, 2002 after 88 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: 1 generation back to K922123 (1993). 3 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K003190: EN Bloc Biopsy System, Neothermia Corp. (2001) Summary page 1.
- 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.
- K922123: Auto Suture Disposable Endoscopic Specimen Pouch, United States Surgical, A Division of Tyco Healthc (1993) Summary page 1.

## Most influential descendants
- K023601: Rubicor Encapsule Breast Biopsy Device, Model 30086 (2002), 4 descendants of its own
- 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 Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.

Source page: https://510kreport.com/device/K020047
Methodology: https://510kreport.com/methodology