# K062528: Tissue Site Marking System

- Pathway: 510(k) (Traditional)
- Applicant: Suros Surgical Systems, Inc.
- Decided: Jan 26, 2007 after 150 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.
12 later devices descend from it; 4 cite it directly.
2 of 13 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
- K072913: Securmark Biopsy Site Identification System (2008), 10 descendants of its own
- 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

## Indications for use
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

Source page: https://510kreport.com/device/K062528
Methodology: https://510kreport.com/methodology