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510(k) K941748

STERI-VAC GAS STERILIZER MODEL 8XL by 3M Health Care, Ltd. — Product Code FLF

K941748 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "STERI-VAC GAS STERILIZER MODEL 8XL". The FDA issued a decision of Substantially Equivalent on December 2, 1994. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1994
Date Received
April 8, 1994
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 3M Health Care, Ltd.

  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (March 31, 1995)
  • K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (March 6, 1995)
  • K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX (February 10, 1994)
  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932422 — 3M TEGADERM HP TRANSPARENT DRESSING (December 27, 1993)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933005 — AVI MODEL 600 SYRINGE PUMP (October 25, 1993)
  • K933006 — AVI INFUSION PUMPS, ADDITIONAL INTENDED USE (October 25, 1993)

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