PJJ · Class II · 21 CFR 880.6860

FDA Product Code PJJ: Two Or More Sterilant Sterilizer

Intended For Use In Terminal Sterilization Of Cleaned, Rinsed, And Dried Metal And Non-metal Reusable Medical Devices In Health Care Facilities.

Leading manufacturers include Tso3, Inc. and Ts03, Inc..

6
Total
6
Cleared
182d
Avg days
2014
Since

FDA 510(k) Cleared Two Or More Sterilant Sterilizer Devices (Product Code PJJ)

6 devices
1–6 of 6
Cleared Jul 19, 2019
STERIZONE(R) VP4 Sterilizer
K190260
Tso3, Inc.
General Hospital · 161d
Cleared May 09, 2018
STERIZONE VP4 Sterilizer
K172191
Tso3, Inc.
General Hospital · 293d
Cleared Mar 13, 2018
STERIZONE VP4 Sterilizer
K173694
Tso3, Inc.
General Hospital · 102d
Cleared Jun 30, 2016
STERIZONE Sterilizer
K153689
Tso3, Inc.
General Hospital · 190d
Cleared Mar 24, 2016
STERIZONE VP4 Sterilizer
K153392
Ts03, Inc.
General Hospital · 121d
Cleared Dec 17, 2014
STERIZONE STERILIZER
K141163
Tso3, Inc.
General Hospital · 226d

About Product Code PJJ - Regulatory Context