ClearanceBrief
Panels › Gastroenterology, Urology › Product code FEB · Class 2

Accessories, Cleaning, For Endoscope

Regulation 876.1500

1510(k)s in 12 months (58 all time)
20recalls in 12 months (43 all time)
43recalls that name a 510(k)
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Top companies in FEB

DateFirm and productCodeLinked 510(k)
Oct 14, 2026Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Open, Classified
FEBK082988
Oct 14, 2026Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Open, Classified
FEBK082988
Oct 14, 2026Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Open, Classified
FEBK082988
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Open, Classified
FEBK201920
Apr 22, 2026Olympus Corporation of the Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Open, Classified
FEBK201920
Mar 20, 2026Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Open, Classified
FEBK103264
Mar 20, 2026Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Open, Classified
FEBK201920
Dec 2, 2025Aizu Olympus Co., Ltd.
Olympus OER-Mini
Open, Classified
FEBK120357
Dec 2, 2025Aizu Olympus Co., Ltd.
Olympus OER-Pro
Open, Classified
FEBK103264
Dec 2, 2025Aizu Olympus Co., Ltd.
Olympus OER-Elite
Open, Classified
FEBK201920
Aug 8, 2024Steris Corporation
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids di
Open, Classified
FEBK092387
Aug 8, 2024Steris Corporation
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope
Open, Classified
FEBK102996
Aug 8, 2024Steris Corporation
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope
Open, Classified
FEBK102996
Aug 8, 2024Steris Corporation
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Re
Open, Classified
FEBK102996
Feb 7, 2024Olympus Corporation of the Americas
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible
Open, Classified
FEBK103264
Dec 22, 2023Steris Corporation
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLY
Open, Classified
FEBK082988
K102996 +1
Aug 23, 2023Olympus Corporation of the Americas
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, G
Open, Classified
FEBK103264
Aug 4, 2023Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Open, Classified
FEBK201920
Aug 4, 2023Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Open, Classified
FEBK120357
Aug 4, 2023Olympus Corporation of the Americas
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Open, Classified
FEBK103264
Dec 13, 2021Olympus Corporation of the Americas
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Terminated
FEBK190969
K201920
Oct 7, 2020Steris Corporation
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Terminated
FEBK181865
Jan 9, 2017Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant C
Terminated
FEBK040883
K061889 +3
Oct 19, 2016Olympus Corporation of the Americas
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Terminated
FEBK103264
Jun 5, 2015Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level di
Terminated
FEBK140977
Jun 5, 2015Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfecta
Terminated
FEBK140977
Apr 18, 2013Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Terminated
FEBK082392
Apr 15, 2013Advanced Sterilization Products
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Terminated
FEBK082392
Aug 12, 2010Minntech Corp
DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endo
Terminated
FEBK914145
Nov 7, 2008Advanced Sterilization Products
ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, subme
Terminated
FEBK832458
Aug 8, 2008Advanced Sterilization Products
EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and
Terminated
FEBK040883
K061899
Aug 8, 2008Advanced Sterilization Products
EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high
Terminated
FEBK040883
K061899
May 4, 2007Custom Ultrasonics, Inc.
83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
Terminated
FEBK061430

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