# K040842: Senorx Biopsy Device II

- Pathway: 510(k) (Special)
- Applicant: Senorx, Inc.
- Decided: Apr 30, 2004 after 29 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093512: Encor Breast Biopsy System (2009), 5 descendants of its own
- K111100: Encor Enspire Breast Biopsy System (2011), 3 descendants of its own
- K233220: EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (2023), 2 descendants of its own
- K252681: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (2025), 1 descendant of its own
- K262571: EnCor EnCompass™ Breast Biopsy and Tissue Removal System (2026), 0 descendants of its own

## Recalls of this device
- Jan 3, 2020 · Class II · Z-1433-2020: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to ob
- Jan 3, 2020 · Class II · Z-1431-2020: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to ob
- Jan 3, 2020 · Class II · Z-1432-2020: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to ob
- Jan 3, 2020 · Class II · Z-1434-2020: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to ob
- May 2, 2019 · Class II · Z-2211-2019: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
- May 2, 2019 · Class II · Z-2214-2019: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
- May 2, 2019 · Class II · Z-2210-2019: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
- May 2, 2019 · Class II · Z-2209-2019: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
- May 2, 2019 · Class II · Z-2212-2019: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
- May 2, 2019 · Class II · Z-2213-2019: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

## Indications for use
The SenoRx Biopsy Device II 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/K040842
Methodology: https://510kreport.com/methodology