# K090611: Revolution Full Core Biopsy

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Jun 4, 2009 after 90 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: 1 generation back to K904987 (1991). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K904987: Vibronics Auto Core Biopsy Device (Acbd), Vibronics (1991) Summary page 1.

## Most influential descendants
- K243886: ExpressCore Biopsy Device (2025), 0 descendants of its own
- K112945: Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM , W/Hiliter 18GAX15CM (2011), 0 descendants of its own

## Indications for use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

Source page: https://510kreport.com/device/K090611
Methodology: https://510kreport.com/methodology