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)
Top companies in FEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corporation of the Americas | 0 | 21 |
| STERIS Corporation | 4 | 9 |
| Advanced Sterilization Products | 4 | 8 |
| Custom Ultrasonics | 4 | 1 |
| Olympus Medical Systems Corp. | 5 | 0 |
| Keymed, Inc. | 4 | 0 |
| Medivators, Inc. | 4 | 0 |
| Aizu Olympus Co., Ltd. | 0 | 3 |
| Cox Medical Ent., Inc. | 3 | 0 |
| Medivators Reprocessing Systems | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 Open, Classified |
FEB | K082988 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus 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 |
FEB | K201920 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. Open, Classified |
FEB | K103264 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. Open, Classified |
FEB | K201920 |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Mini Open, Classified |
FEB | K120357 |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Pro Open, Classified |
FEB | K103264 |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Elite Open, Classified |
FEB | K201920 |
| Aug 8, 2024 | Steris 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 |
FEB | K092387 |
| Aug 8, 2024 | Steris 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 |
FEB | K102996 |
| Aug 8, 2024 | Steris 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 |
FEB | K102996 |
| Aug 8, 2024 | Steris 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 |
FEB | K102996 |
| Feb 7, 2024 | Olympus 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 |
FEB | K103264 |
| Dec 22, 2023 | Steris 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 |
FEB | K082988 K102996 +1 |
| Aug 23, 2023 | Olympus 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 |
FEB | K103264 |
| Aug 4, 2023 | Olympus 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 |
FEB | K201920 |
| Aug 4, 2023 | Olympus 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 |
FEB | K120357 |
| Aug 4, 2023 | Olympus 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 |
FEB | K103264 |
| Dec 13, 2021 | Olympus 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 |
FEB | K190969 K201920 |
| Oct 7, 2020 | Steris 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 |
FEB | K181865 |
| Jan 9, 2017 | Advanced 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 |
FEB | K040883 K061889 +3 |
| Oct 19, 2016 | Olympus Corporation of the Americas OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector Terminated |
FEB | K103264 |
| Jun 5, 2015 | Advanced 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 |
FEB | K140977 |
| Jun 5, 2015 | Advanced 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 |
FEB | K140977 |
| Apr 18, 2013 | Advanced 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 |
FEB | K082392 |
| Apr 15, 2013 | Advanced 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 |
FEB | K082392 |
| Aug 12, 2010 | Minntech 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 |
FEB | K914145 |
| Nov 7, 2008 | Advanced 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 |
FEB | K832458 |
| Aug 8, 2008 | Advanced 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 |
FEB | K040883 K061899 |
| Aug 8, 2008 | Advanced 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 |
FEB | K040883 K061899 |
| May 4, 2007 | Custom Ultrasonics, Inc. 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc. Terminated |
FEB | K061430 |
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