# K982401: Prostate Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Remington Medical, Inc.
- Decided: Sep 8, 1998 after 60 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 3 (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
- Aug 29, 2012 · Class II · Z-0028-2013: Sterility of the product may be compromised.
- Jan 19, 2007 · Not classified · Z-0673-2007: Pouches were not sealed prior to sterilization.
- Feb 15, 2005 · Not classified · Z-0697-05: The stylet hub detaches from the stylet needle.

## Indications for use
Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.

Source page: https://510kreport.com/device/K982401
Methodology: https://510kreport.com/methodology