# K050120: Easy Core Biopsy System II

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Feb 8, 2005 after 21 days
- Product code: FCG (Biopsy Needle)
- 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: 1 generation back to K040893 (2004). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040893: Easy Core Biopsy System, Boston Scientific Corp (2004) Summary page 1.

## Most influential descendants
- K101832: Biopince Ultra Full Core Biopsy Instrument (2010), 1 descendant of its own
- K102756: Surecore Biopsy Device (2011), 0 descendants of its own

## Indications for use
The proposed device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.

Source page: https://510kreport.com/device/K050120
Methodology: https://510kreport.com/methodology