# K180175: SignalMark Lung Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: View Point Medical, Inc.
- Decided: Dec 7, 2018 after 319 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K041331 (2004). 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)
- K041331: Biopsy Sciences, LLC, Lung Biopsy Site Marker, Biopsy Sciences, LLC (2004) Summary page 5.

## Indications for use
The SignalMark Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Source page: https://510kreport.com/device/K180175
Methodology: https://510kreport.com/methodology