# K070275: Flexible Loop Electrosurgical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Rubicor Medical, Inc.
- Decided: Mar 9, 2007 after 39 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K922123 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052506: Rubicor Encapsule Breast Biopsy Device, Model 31108, Rubicor Medical, Inc. (2005) Summary page 1.
- K012799: ES-2000 Shape Select Electrosurgical Scalpel, Senorx, Inc. (2001)
- K020711: Wallach Loop Electrode, Wallach Surgical Devices, Inc. (2002) Summary page 1.
- K973346: Uncoated Electrosurgical Electrode, Megadyne Medical Products, Inc. (1997) Summary page 1.

## Indications for use
The Rubicor Flexible Loop Electrosurgical Electrode 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. It is also intended to be used to cut soft tissue. The Rubicor Flexible Loop Electrosurgical Electrode 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/K070275
Methodology: https://510kreport.com/methodology