# K192371: BioZorb SP Marker

- Pathway: 510(k) (Special)
- Applicant: Focal Therapeutics
- Decided: Sep 26, 2019 after 27 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.
No later device cites it as a predicate yet.
2 of 15 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.

## Indications for use
The BioZorb SP Marker 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/K192371
Methodology: https://510kreport.com/methodology