# K143115: The VersaJet II Hydrosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 15, 2015 after 258 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K972069 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110958: Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet Footswitch, Smith & Nephew, Inc. (2011) Summary page 4.

## Most influential descendants
- K220964: VERSAJET Hydrosurgery System (III) (2023), 0 descendants of its own

## Indications for use
The VersaJet II Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.

Source page: https://510kreport.com/device/K143115
Methodology: https://510kreport.com/methodology