# K001807: Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Uroscience, Inc.
- Decided: May 3, 2001 after 322 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.
49 later devices descend from it; 3 cite it directly.
2 of 50 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
- K032347: Biomarc Tissue Marker (2003), 45 descendants of its own
- 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
- K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker (2001), 12 descendants of its own

Source page: https://510kreport.com/device/K001807
Methodology: https://510kreport.com/methodology