# K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide

- Pathway: 510(k) (Special)
- Applicant: Envisioneering, LLC
- Decided: Dec 21, 2007 after 17 days
- Product code: FCG (Biopsy Needle)
- 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: 3 generations back to K875128 (1988). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041638: Targetscan Biopsy Kit, Envisioneering, LLC (2004) Summary page 1.
- K041637: Targetscan Transrectal Ultrasound System, Envisioneering, LLC (2004) Summary page 1.

## Most influential descendants
- K081323: Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 (2008), 0 descendants of its own

## Indications for use
The TargetScan Biopsy Kit intended use is for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system.

Source page: https://510kreport.com/device/K073399
Methodology: https://510kreport.com/methodology