# K012004: Easy Guide Electrosurgical Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Sep 25, 2001 after 90 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: 1 generation back to K790187 (1979). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963813: Sure Core Biopsy Kit, Interventional Concepts, Inc. (1997) Summary page 1.
- K925984: Acucise Electrosurgical Trocar, Applied Medical Resources (1993) Summary page 1.
- K790187: Bovie Hand Control, Sybron Corp. (1979) Summary page 1.

## Most influential descendants
- K013641: Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,Connector Cords and Footswitch), Vacuums (2002), 1 descendant of its own
- 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 Easy Guide™ Electrosurgical Access Device is indicated for use to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

Source page: https://510kreport.com/device/K012004
Methodology: https://510kreport.com/methodology