# K081170: Prostate Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: May 28, 2008 after 34 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K011402 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080698: Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP, Senorx, Inc. (2008) Summary page 1.
- K071614: Fiducial Markers, Civco (2007) Summary page 1.

## Indications for use
The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue.

Source page: https://510kreport.com/device/K081170
Methodology: https://510kreport.com/methodology