# K252388: Vanquish Water Vapor Ablation Device

- Pathway: 510(k) (Traditional)
- Applicant: Francis Medical, Inc.
- Decided: Nov 26, 2025 after 118 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K951245 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150786: Rezum System, Nxthera, Inc. (2015) Summary page 5.

## Indications for use
The Vanquish Water Vapor Ablation System is indicated for the thermal ablation of targeted prostate tissue via a transurethral approach.

Source page: https://510kreport.com/device/K252388
Methodology: https://510kreport.com/methodology