# K262571: EnCor EnCompass™ Breast Biopsy and Tissue Removal System

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Aug 14, 2026 after 21 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: 6 generations back to K991980 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252681: EnCor EnCompass™ Breast Biopsy and Tissue Removal System, Bard Peripheral Vascular, Inc. (2025) Summary page 5.

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

Source page: https://510kreport.com/device/K262571
Methodology: https://510kreport.com/methodology