# Focal Therapeutics

- Location (FDA's records): Portola Valley, CA
- FDA decisions: 5 (2012–2019): 5 510(k) clearances
- Product codes: NEU (4), IYE (1)
- Predicates its devices cite: 15 (6 its own); citations of its devices by later devices: 10 (6 its own)
- Recalls linked to its devices: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Civco: 2 (https://510kreport.com/company/civco)
- Carbon Medical Technologies, Inc.: 2 (https://510kreport.com/company/carbon-medical-technologies)
- Suros Surgical Systems, Inc.: 1 (https://510kreport.com/company/suros-surgical-systems)
- Suros Surgical Systems, Inc. A Hologic Company: 1 (https://510kreport.com/company/suros-surgical-systems-a-hologic)
- Senorx, Inc.: 1 (https://510kreport.com/company/senorx)
- Artemis Medical, Inc.: 1 (https://510kreport.com/company/artemis-medical)
- Cortex Manufacturing, Inc.: 1 (https://510kreport.com/company/cortex-manufacturing)

## Firms that cite its devices most
- Elucent Medical, Inc.: 2 (https://510kreport.com/company/elucent-medical)
- Sonavex, Inc.: 1 (https://510kreport.com/company/sonavex)
- Radiation Products, LLC: 1 (https://510kreport.com/company/radiation-products)

## Its most-cited devices
- K143484: BioZorb Marker (2015), cited by 5
- K152070: BioZorb LP Marker (2015), cited by 4
- K113202: Tissue Marker (2012), cited by 1

## Recent decisions
- K192371: BioZorb SP Marker (Sep 26, 2019)
- K171467: BioZorb Marker GOLD / LP Marker GOLD (Nov 9, 2017)
- K152070: BioZorb LP Marker (Aug 26, 2015)
- K143484: BioZorb Marker (Jun 29, 2015)
- K113202: Tissue Marker (Feb 28, 2012)

Source page: https://510kreport.com/company/focal-therapeutics