# K013641: Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,Connector Cords and Footswitch), Vacuums

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Jan 29, 2002 after 85 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: 2 generations back to K790187 (1979). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K003297: Mammotome Hand Held Probe, Model MHH8, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K012004: Easy Guide Electrosurgical Access Device, Senorx, Inc. (2001) Summary page 1.

## Most influential descendants
- K021707: Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders (2002), 0 descendants of its own

## Indications for use
The SenoRx Biopsy Device System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended 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/K013641
Methodology: https://510kreport.com/methodology