# K031938: Gel Mark Iii Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Sep 5, 2003 after 74 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.
3 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Gel Mark Biopsy Site Marker: named in the summary without a submission number
- (no number) Gel Mark Ultra Biopsy Site Marker: named in the summary without a submission number
- (no number) MammoMark Biopsy Site Marker: named in the summary without a submission number

## Most influential descendants
- K081085: Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GS (2008), 2 descendants of its own
- K131654: Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker (2013), 1 descendant of its own
- K153189: Beacon Tissue Marker (SE) (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K031938
Methodology: https://510kreport.com/methodology