# K000060: Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Mar 27, 2000 after 77 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022326: Radiomed Marker (2003), 21 descendants of its own
- K031206: Radiomed Soft Tissue Marker (2003), 20 descendants of its own
- K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker (2001), 12 descendants of its own
- K070305: Pre-Loaded Visicoil (2007), 11 descendants of its own
- K072219: Cytophil Tissue Marker (2008), 10 descendants of its own

Source page: https://510kreport.com/device/K000060
Methodology: https://510kreport.com/methodology