# K102768: Secrmark Biopsy Site Marking System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Dec 2, 2010 after 69 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: 1 generation back to K062528 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 2.

## 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/K102768
Methodology: https://510kreport.com/methodology