# K032347: Biomarc Tissue Marker

- Pathway: 510(k) (Special)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Aug 21, 2003 after 22 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
Longest line of descent: 1 generation back to K001807 (2001). 1 ancestor in all.
45 later devices descend from it; 2 cite it directly.
2 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001807: Tissue Marker, Advanced Uroscience, Inc. (2001)

## 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
The BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Source page: https://510kreport.com/device/K032347
Methodology: https://510kreport.com/methodology