Home / 510(k) Clearances / K101409

510(k) K101409

SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM by STERIS Corporation — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2010
Date Received
May 19, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type

Other clearances by STERIS Corporation

  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (May 2, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)

Other clearances for product code MED

  • K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liq (October 3, 2023)
  • K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (March 28, 2023)
  • K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 28, 2022)
  • K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 7, 2021)
  • K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (May 12, 2021)
  • K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (December 10, 2019)
  • K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (September 5, 2019)
  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (January 31, 2019)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)