# K040266: Core Needle Biopsy

- Pathway: 510(k) (Traditional)
- Applicant: Remington Medical, Inc.
- Decided: Jul 9, 2004 after 155 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Feb 7, 2011 · Not classified · Z-1577-2011: There is a potential for the needle hubs to break during use.
- Feb 7, 2011 · Not classified · Z-1575-2011: There is a potential for the needle hubs to break during use.
- Feb 7, 2011 · Not classified · Z-1576-2011: There is a potential for the needle hubs to break during use.
- Feb 7, 2011 · Not classified · Z-1574-2011: There is a potential for the needle hubs to break during use.
- Feb 7, 2011 · Not classified · Z-1573-2011: There is a potential for the needle hubs to break during use.

## Indications for use
The Remington CenterFire Is Intended for use In obtaining biopsies from soft tissue such as liver, kidney, prostate, breast spleen and various soft tissue tumors. It Is not Intended for use In the hone.

Source page: https://510kreport.com/device/K040266
Methodology: https://510kreport.com/methodology