# K021813: Hydrocision General Surgery Fluidjet System

- Pathway: 510(k) (Traditional)
- Applicant: Hydrocision, Inc.
- Decided: May 9, 2003 after 340 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: 3 generations back to K972069 (1997). 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)
- K011612: Modification to Hydrocision Debridement System, Hydrocision, Inc. (2001)
- K992855: XPS Straightshot or Model 2000 Microdebrider System or XPS Powersculpt, Xomed, Inc. (2000) Summary page 1.
- K012464: Helix Hydro-Jet, Andreas Pein Medizintechnik GmbH (2001)
- K844403: Model Force 2 Electrosurgical Generator, Valleylab, Inc. (1985) Summary page 1.

## Indications for use
The intended use of the Hydrocision General Surgery FluidJet System is for the tangential cutting, resection and removal of soft tissue or fluid from the body. Hydrocision General Surgery FluidJet System is not intended for use in suction lipoplasty procedures.

Source page: https://510kreport.com/device/K021813
Methodology: https://510kreport.com/methodology