# 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)

- Pathway: 510(k) (Special)
- Applicant: Senorx, Inc.
- Decided: Oct 27, 2023 after 29 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: 4 generations back to K991980 (1999). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111100: Encor Enspire Breast Biopsy System, C.R. Bard, Inc. (2011) Summary page 5.
- K093512: Encor Breast Biopsy System, Senorx, Inc. (2009) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The EnCor Enspire™ Breast Biopsy System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality.

Source page: https://510kreport.com/device/K233220
Methodology: https://510kreport.com/methodology