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510(k) K852115

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER by Ars Enterprises, Inc. — Product Code FLF

K852115 is an FDA 510(k) premarket notification submitted by Ars Enterprises, Inc. for the device "ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER". The FDA issued a decision of Substantially Equivalent on November 1, 1985. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Ars Enterprises, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1985
Date Received
May 15, 1985
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 Ars Enterprises, Inc.

  • K852114 — ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 (September 27, 1985)
  • K852113 — ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 (September 27, 1985)
  • K831356 — STEAM STERILIZER (July 18, 1984)

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)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
  • 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)

FDA data resources