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510(k) K201920

Endoscope Reprocessor OER-Elite by Olympus Medical Systems Corp. — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2020
Date Received
July 10, 2020
Clearance Type
Special
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 Olympus Medical Systems Corp.

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  • K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)
  • K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (June 5, 2025)
  • K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single (May 27, 2025)
  • K250296 — Disposable Distal Attachment D-201 Series (May 1, 2025)

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)
  • 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)
  • K162120 — Scope-Assist Flushing Sink (April 28, 2017)