# K081323: Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Jul 22, 2008 after 71 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: 4 generations back to K875128 (1988). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide, Envisioneering, LLC (2007) Summary page 1.

## Indications for use
Performing ultrasound guided biopsies of the prostate

Source page: https://510kreport.com/device/K081323
Methodology: https://510kreport.com/methodology