# K021707: Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step Holders

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Aug 14, 2002 after 83 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K790187 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012023: Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable, Senorx, Inc. (2001) Summary page 1.
- K012799: ES-2000 Shape Select Electrosurgical Scalpel, Senorx, Inc. (2001)
- K013641: Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power Cord,Connector Cords and Footswitch), Vacuums, Senorx, Inc. (2002)

## Indications for use
The Single Step Biopsy Device System is intended for breast lesion localization and diagnostic tissue sampling for histological 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/K021707
Methodology: https://510kreport.com/methodology