# Nxthera (A Boston Scientific Company)

- Location (FDA's records): Marlboro, MA
- FDA decisions: 2 (2019–2019): 2 510(k) clearances
- Product codes: KNS (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 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
- Nxthera, Inc.: 1 (https://510kreport.com/company/nxthera)

## Firms that cite its devices most
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K191505: Rezum System (2019), cited by 1
- K190093: Rezum Delivery Device, Rezum Generator (2019), cited by 1

## Recent decisions
- K191505: Rezum System (Aug 2, 2019)
- K190093: Rezum Delivery Device, Rezum Generator (Mar 25, 2019)

Source page: https://510kreport.com/company/nxthera-a-boston-scientific
