# K102608: Securmark Biopsy Site Marking System

- Pathway: 510(k) (Special)
- Applicant: Suros Surgical Systems, Inc. A Hologic Company
- Decided: Oct 8, 2010 after 28 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072913: Securmark Biopsy Site Identification System, Suros Surgical Systems, Inc. A Hologic Company (2008) Summary page 1.
- K062528: Tissue Site Marking System, Suros Surgical Systems, Inc. (2007) Summary page 2.

## Indications for use
The SecurMark Biopsy Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue,

Source page: https://510kreport.com/device/K102608
Methodology: https://510kreport.com/methodology