# K011402: Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Jul 16, 2001 after 70 days
- Product code: FZP (Clip, 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.
11 later devices descend from it; 2 cite it directly.
2 of 12 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
- K113202: Tissue Marker (2012), 8 descendants of its own
- K143484: BioZorb Marker (2015), 7 descendants of its own
- K152070: BioZorb LP Marker (2015), 5 descendants of its own
- K180640: SmartClip Soft Tissue Marker (2018), 1 descendant of its own
- K080698: Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP (2008), 1 descendant of its own

Source page: https://510kreport.com/device/K011402
Methodology: https://510kreport.com/methodology