# K080698: Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP

- Pathway: 510(k) (Special)
- Applicant: Senorx, Inc.
- Decided: Mar 31, 2008 after 19 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: 1 generation back to K011402 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011402: Biopsy Site Marker, Senorx, Inc. (2001)
- K040706: Gel Mark IV, Senorx, Inc. (2004) Summary page 1.

## Most influential descendants
- K081170: Prostate Tissue Marker (2008), 0 descendants of its own

## Indications for use
The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Source page: https://510kreport.com/device/K080698
Methodology: https://510kreport.com/methodology