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510(k) K140977

EVOTECH ECR by Advanced Sterilization Products — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2014
Date Received
April 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Advanced Sterilization Products

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  • K234084 — STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indi (July 5, 2024)
  • K220404 — STERRAD NX with ALLClear Technology (May 16, 2022)
  • K212174 — STERRAD 100NX Sterilizer with ALLClear Technology (October 9, 2021)
  • K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRA (July 31, 2017)
  • K162007 — STERRAD NX Sterilizer (February 16, 2017)
  • K160818 — STERRAD® NX Sterilizer with ALLClear™ Technology (September 27, 2016)
  • K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology (September 26, 2016)

Other clearances for product code FEB

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  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (June 30, 2023)
  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K201920 — Endoscope Reprocessor OER-Elite (September 1, 2020)
  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K190969 — ENDOSCOPE REPROCESSOR OER-Elite (July 9, 2019)
  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)