# K130282: Remington Medical Centrefire 22 Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Remington Medical, Inc.
- Decided: May 13, 2013 after 97 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: 2 generations back to K871390 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962969: Medical Device Technologies, Inc.Ultra, Medical Device Technologies, Inc. (1996) Summary page 1.

## Indications for use
The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.

Source page: https://510kreport.com/device/K130282
Methodology: https://510kreport.com/methodology