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510(k) K181472

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor by Advanced Sterilization Products (Asp) — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2019
Date Received
June 4, 2018
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 (Asp)

  • K192025 — STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader (January 23, 2020)
  • K182404 — STERRAD VELOCITY Biological Indicator (December 27, 2018)
  • K170039 — STERRAD VELOCITY Biological Indictator and Reader (June 20, 2017)
  • K152189 — EVOTECH ECR (July 20, 2016)

Other clearances for product code FEB

  • K241168 — System 83 Revolve Endoscope Washer/Disinfector (December 19, 2024)
  • 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)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)
  • K162120 — Scope-Assist Flushing Sink (April 28, 2017)