# K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

- Pathway: 510(k) (Traditional)
- Applicant: Xaga Surgical
- Decided: Feb 27, 2025 after 223 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: 4 generations back to K890925 (1989). 34 ancestors in all.
No later device cites it as a predicate yet.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162588: Möller Medical Biopsy Needles and Systems, Moller Medical GmbH (2017) Summary page 5.

## Indications for use
The Forsvall biopsy needle is intended to collect histological biopsy samples from soft tissue intended for clinical examination. The Forsvall biopsy needle is part of the Forsvall biopsy needle system for prostate biopsy and shall be used together with the Forsvall biopsy gun. The Forsvall biopsy gun is intended to be used by medical professionals, together with the Forsvall biopsy needle, on male patients to obtain soft tissue samples. The Forsvall biopsy gun is part of the Forsvall biopsy needle system for prostate biopsy. The Forsvall biopsy needle system for prostate biopsy is indicated whenever there is a need to obtain prostate biopsy samples.

Source page: https://510kreport.com/device/K242128
Methodology: https://510kreport.com/methodology