# K023450: Biopsy Site Tissue Marker Device

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Dec 19, 2002 after 65 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.
45 later devices descend from it; 2 cite it directly.
2 of 46 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 no predicate by number.

## Most influential descendants
- K042296: Biomarc Preloaded Tissue Marker Device (2004), 44 descendants of its own
- K063193: Modification to Biomarc Tissue Marker (2006), 25 descendants of its own
- K070436: Biomarc Gold Tissue Marker (2007), 17 descendants of its own
- K111895: Echotip (R) Ultra Fiducial Needle (2012), 10 descendants of its own
- K072913: Securmark Biopsy Site Identification System (2008), 10 descendants of its own

## Indications for use
These devices are intended to be used to mark an open or percutaneous biopsy site to radiographically mark the location of the biopsy site.

Source page: https://510kreport.com/device/K023450
Methodology: https://510kreport.com/methodology