# K113202: Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Focal Therapeutics
- Decided: Feb 28, 2012 after 120 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
Longest line of descent: 4 generations back to K001807 (2001). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062528: Tissue Site Marking System, Suros Surgical Systems, Inc. (2007) Summary page 1.
- K072913: Securmark Biopsy Site Identification System, Suros Surgical Systems, Inc. A Hologic Company (2008) Summary page 1.
- K011402: Biopsy Site Marker, Senorx, Inc. (2001)
- K032217: 14G Cormark Biopsy Site Identifier, Artemis Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K233639: SmartClip Secure Soft Tissue Marker (2024), 0 descendants of its own
- K192371: BioZorb SP Marker (2019), 0 descendants of its own

## Indications for use
The BioZorb T' Tissue Marker is indicated for radiographic marking of sites in soft tissue.

Source page: https://510kreport.com/device/K113202
Methodology: https://510kreport.com/methodology