# Nxthera, Inc.

- Location (FDA's records): Maple Grove, MN
- FDA decisions: 3 (2015–2018): 3 510(k) clearances
- Product codes: KNS (3)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Urologix, Inc.: 1 (https://510kreport.com/company/urologix)

## Firms that cite its devices most
- Francis Medical, Inc.: 1 (https://510kreport.com/company/francis-medical)
- Nxthera (A Boston Scientific Company): 1 (https://510kreport.com/company/nxthera-a-boston-scientific)

## Its most-cited devices
- K150786: Rezum System (2015), cited by 2
- K160417: Rezum System (2016), cited by 1
- K180237: Rezum System (2018), cited by 1

## Recent decisions
- K180237: Rezum System (Feb 27, 2018)
- K160417: Rezum System (Mar 17, 2016)
- K150786: Rezum System (Aug 27, 2015)

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