PJJ — Two Or More Sterilant Sterilizer Class II

FDA Device Classification

Classification Details

Product Code
PJJ
Device Class
Class II
Regulation Number
880.6860
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190260tso3STERIZONE(R) VP4 SterilizerJuly 19, 2019
K172191tso3STERIZONE VP4 SterilizerMay 9, 2018
K173694tso3STERIZONE VP4 SterilizerMarch 13, 2018
K153689tso3STERIZONE SterilizerJune 30, 2016
K153392ts03STERIZONE VP4 SterilizerMarch 24, 2016
K141163tso3STERIZONE STERILIZERDecember 17, 2014