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510(k) K931872

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER by American Sterilizer Co. — Product Code FLF

K931872 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER". The FDA issued a decision of Substantially Equivalent on February 7, 1994. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1994
Date Received
April 14, 1993
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 American Sterilizer Co.

  • K943288 — AMSCO SQ240 SURGICAL LIGHT (October 17, 1994)
  • K922485 — CHEMDI-VHP CHEMICAL INDICATOR (September 29, 1993)
  • K930493 — QUANTUM 3080 SURGICAL TABLE (June 22, 1993)
  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K896674 — AMSCO QUANTUM LIGHT (January 3, 1990)
  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K880198 — GEMINI SURGICAL LIGHT (February 10, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K844479 — CHEMSPOR (November 25, 1985)

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