Atlas FDA

Endoscope Reprocessor OER-Elite

FDA 510(k) clearance K201920 · decided 2020-09-01

Clearance details

K-number
K201920
Device name
Endoscope Reprocessor OER-Elite
Applicant
Olympus Medical Systems Corp.
Decision
Substantially Equivalent
Date received
2020-07-10
Decision date
2020-09-01
Days to decision
53 days
Clearance type
Special
Product code
FEB
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hachioji-Shi, JP
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
System 83 Revolve Endoscope Washer/Disinfector (K241168)Wassenburg Medical, Inc.2024-12-19
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433)STERIS Corporation2024-12-02
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930)STERIS Corporation2023-06-30
SCOPE BUDDY PLUS Endoscope Flushing Aid (K213833)Medivators, Inc.2022-01-14
System 83 Plus Washer/Disinfector (K173590)Custom Ultrasonics, Inc.2020-03-30
ENDOSCOPE REPROCESSOR OER-Elite (K190969)Olympus Medical Systems Corp.2019-07-09
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (K181472)Advanced Sterilization Products (Asp)2019-04-23
Acu-sInQ Complete Endoscope Cleaning Aid System (K181865)STERIS Corporation2018-12-14
Advantage Plus Pass-Thru (K172677)Medivators, Inc.2017-12-19
Scope-Assist Flushing Sink (K162120)Custom Ultrasonics, Inc.2017-04-28
Scope Buddy Plus Endoscope Flushing Aid (K162128)Medivators, Inc.2016-12-21
EVOTECH ECR (K152189)Advanced Sterilization Products (Asp)2016-07-20

Recalls involving this device

RecordFirmDate
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be i recall (Z-1898-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 recall (Z-1899-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 recall (Z-1900-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. recall (Z-1901-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. recall (Z-1902-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. recall (Z-1903-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. recall (Z-1904-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. recall (Z-1905-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. recall (Z-1906-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. recall (Z-1907-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. recall (Z-1908-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. recall (Z-1909-2026)Olympus Corporation of the Americas2026-04-22
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. recall (Z-1612-2026)Olympus Corporation of the Americas2026-03-20
Olympus OER-Elite recall (Z-0872-2026)Aizu Olympus Co., Ltd.2025-12-02
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of recall (Z-2344-2023)Olympus Corporation of the Americas2023-08-04