# K011612: Modification to Hydrocision Debridement System

- Pathway: 510(k) (Special)
- Applicant: Hydrocision, Inc.
- Decided: Jun 22, 2001 after 28 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: 2 generations back to K972069 (1997). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991383: Hydrocision Debdridement System, Hydrocision, Inc. (2000) Summary page 1.

## Most influential descendants
- K060782: Versajet Hydrosurgery System and Handpiece (2006), 9 descendants of its own
- K062544: AR1000 Ultrasonic Wound Therapy System (2007), 5 descendants of its own
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K110958: Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet Footswitch (2011), 2 descendants of its own
- K143115: The VersaJet II Hydrosurgery System (2015), 1 descendant of its own

## Indications for use
The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

Source page: https://510kreport.com/device/K011612
Methodology: https://510kreport.com/methodology