510(k) Report

Devices descending from K011612

11 later devices reach Modification to Hydrocision Debridement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060782Versajet Hydrosurgery System and HandpieceSmith & Nephew Wound Management20069—
+1K021813Hydrocision General Surgery Fluidjet SystemHydrocision, Inc.20030—
+2K110958Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet…Smith & Nephew, Inc.20112—
+2K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+2K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+3K143115The VersaJet II Hydrosurgery SystemSmith & Nephew, Inc.20151—
+3K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+3K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+3K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+4K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited20230—
+4K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—