# K180640: SmartClip Soft Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Elucent Medical, Inc.
- Decided: Jun 4, 2018 after 84 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: 7 generations back to K001807 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143484: BioZorb Marker, Focal Therapeutics (2015) Summary page 4.
- K152070: BioZorb LP Marker, Focal Therapeutics (2015) Summary page 4.

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

## Indications for use
The implanted SmartClip™ is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Source page: https://510kreport.com/device/K180640
Methodology: https://510kreport.com/methodology