Home / 510(k) Clearances / K150646

510(k) K150646

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

K150646 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 November 18, 2015. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2015
Date Received
March 12, 2015
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

Other clearances by Andersen Sterilizers, Inc.

  • K213296 — Anprolene SteriTest RRBI (April 12, 2022)
  • K202879 — EOGas 4 Endo-SteriTest RRBI (March 3, 2021)
  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K200335 — Sterisheet Sterilization Wrap (November 12, 2020)
  • K200336 — Tyvek Sterilization Pouches with Chevron Seal (November 12, 2020)
  • K192980 — EOGas 4 Endo-SteriTest (November 12, 2020)
  • K200334 — AN1036 Dosimeter (November 12, 2020)
  • K170437 — Sterisheet Sterilization Wrap (November 1, 2017)
  • K170439 — AN87 Dosimeter (November 1, 2017)
  • K170427 — Anprolene SteriTest (October 31, 2017)

Other clearances for product code FLF

  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (January 8, 2015)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

FDA data resources