# K220964: VERSAJET Hydrosurgery System (III)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: May 16, 2023 after 410 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: 6 generations back to K972069 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143115: The VersaJet II Hydrosurgery System, Smith & Nephew, Inc. (2015) Summary page 4.

## Indications for use
The VERSAJET III Hydrosurgery System cuts, ablates and removes tissue and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician’s judgment, require sharp debridement: - wound debridement (acute and chronic wounds, burns), - soft tissue debridement and cleansing of surgical sites.

Source page: https://510kreport.com/device/K220964
Methodology: https://510kreport.com/methodology