# HistoSonics, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 4 (2023–2026): 3 510(k) clearances and 1 De Novo grant
- Product codes: QGM (3), QTZ (1)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- DEN220087: Edison System (2023), cited by 1
- K233466: Edison System (2024), cited by 1

## Recent decisions
- K252947: HistoSonics® Planning Tool (May 29, 2026)
- K241902: Edison System (Oct 30, 2024)
- K233466: Edison System (Mar 13, 2024)
- DEN220087: Edison System (Oct 6, 2023)

Source page: https://510kreport.com/company/histosonics