# K040706: Gel Mark IV

- Pathway: 510(k) (Special)
- Applicant: Senorx, Inc.
- Decided: Apr 8, 2004 after 21 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080698: Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP (2008), 1 descendant of its own
- K081170: Prostate Tissue Marker (2008), 0 descendants of its own

## Indications for use
The Gel Mark IV is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.

Source page: https://510kreport.com/device/K040706
Methodology: https://510kreport.com/methodology