Home / 510(k) Clearances / K192978

510(k) K192978

EOGas 4 Ethylene Oxide Gas Sterilizer by Andersen Sterilizers, Inc. — Product Code FLF

K192978 is an FDA 510(k) premarket notification submitted by Andersen Sterilizers, Inc. for the device "EOGas 4 Ethylene Oxide Gas Sterilizer". The FDA issued a decision of Substantially Equivalent on Nov 12, 2020. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Andersen Sterilizers, Inc. has 18 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 12, 2020
Date Received
Oct 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type
510(k)

Other clearances by Andersen Sterilizers, Inc.

  • K213296 — Anprolene SteriTest RRBI (Apr 12, 2022)
  • K202879 — EOGas 4 Endo-SteriTest RRBI (Mar 3, 2021)
  • K192980 — EOGas 4 Endo-SteriTest (Nov 12, 2020)
  • K200334 — AN1036 Dosimeter (Nov 12, 2020)
  • K200335 — Sterisheet Sterilization Wrap (Nov 12, 2020)
  • K200336 — Tyvek Sterilization Pouches with Chevron Seal (Nov 12, 2020)
  • K170439 — AN87 Dosimeter (Nov 1, 2017)
  • K170437 — Sterisheet Sterilization Wrap (Nov 1, 2017)
  • K170427 — Anprolene SteriTest (Oct 31, 2017)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (Oct 31, 2017)

Other clearances for product code FLF

  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (Oct 31, 2017)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (Nov 18, 2015)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (Jan 8, 2015)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (Dec 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (Jul 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (Aug 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (Jun 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (Apr 3, 2003)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (Dec 22, 1994)
  • K905119 — PLAZLYTE(TM) (Dec 22, 1994)

FDA data resources