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510(k) K172191

STERIZONE VP4 Sterilizer by Tso3, Inc. — Product Code PJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2018
Date Received
July 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Two Or More Sterilant Sterilizer
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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

Other clearances by Tso3, Inc.

  • K190260 — STERIZONE(R) VP4 Sterilizer (July 19, 2019)
  • K173694 — STERIZONE VP4 Sterilizer (March 13, 2018)
  • K153689 — STERIZONE Sterilizer (June 30, 2016)
  • K141163 — STERIZONE STERILIZER (December 17, 2014)
  • K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (December 17, 2014)
  • K141698 — STERIZONE CHEMICAL INDICATOR (December 17, 2014)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K080198 — TSO3 OZONE STERILIZATION WRAP (May 30, 2008)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)

Other clearances for product code PJJ

  • K190260 — STERIZONE(R) VP4 Sterilizer (July 19, 2019)
  • K173694 — STERIZONE VP4 Sterilizer (March 13, 2018)
  • K153689 — STERIZONE Sterilizer (June 30, 2016)
  • K153392 — STERIZONE VP4 Sterilizer (March 24, 2016)
  • K141163 — STERIZONE STERILIZER (December 17, 2014)