# K233639: SmartClip Secure Soft Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Elucent Medical, Inc.
- Decided: Dec 20, 2024 after 403 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: 8 generations back to K001807 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180640: SmartClip Soft Tissue Marker, Elucent Medical, Inc. (2018) Summary page 5.

## 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/K233639
Methodology: https://510kreport.com/methodology