Accessories, Cleaning, For Endoscope
FDA product code FEB · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
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).
57510(k) clearances
0PMA approvals
40recalls
Manufacturers
- Olympus Medical Systems Corp. 5
- Advanced Sterilization Products 4
- Keymed, Inc. 4
- Medivators, Inc. 4
- Custom Ultrasonics, Inc. 4
- STERIS Corporation 3
- Cox Medical Ent., Inc. 3
- Medivators Reprocessing Systems 3
- Langford IC Systems, Inc. 2
- United States Endoscopy Group, Inc. 2
- Blue Planet Industries, Inc. 2
- Advanced Sterilization Products (Asp) 2
- Novar Medical Industries 1
- Biosearch Medical Products, Inc. 1
- Viatro, Corp. 1
- Wassenburg Medical, Inc. 1
- H & C Chemical, Inc. 1
- Candela Laser Corp. 1
- Applied Medical Resources Corp 1
- Telemed Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/DisinfectorFEB · Traditional | Wassenburg Medical, Inc. | 12/19/2024SE |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB · Special | STERIS Corporation | 12/02/2024SE |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB · Traditional | STERIS Corporation | 06/30/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | Medivators, Inc. | 01/14/2022SE |
| K201920 | Endoscope Reprocessor OER-EliteFEB · Special | Olympus Medical Systems Corp. | 09/01/2020SE |
| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | Custom Ultrasonics, Inc. | 03/30/2020SE |
| K190969 | ENDOSCOPE REPROCESSOR OER-EliteFEB · Traditional | Olympus Medical Systems Corp. | 07/09/2019SE |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB · Traditional | Advanced Sterilization Products (Asp) | 04/23/2019SE |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB · Traditional | STERIS Corporation | 12/14/2018SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | Medivators, Inc. | 12/19/2017SE |
| K162120 | Scope-Assist Flushing SinkFEB · Traditional | Custom Ultrasonics, Inc. | 04/28/2017SE |
| K162128 | Scope Buddy Plus Endoscope Flushing AidFEB · Traditional | Medivators, Inc. | 12/21/2016SE |
| K152189 | Evotech EcrFEB · Traditional | Advanced Sterilization Products (Asp) | 07/20/2016SE |
| K140977 | Evotech EcrFEB · Traditional | Advanced Sterilization Products | 12/22/2014SE |
| K122172 | System 83 PlusFEB · Special | Custom Ultrasonics | 01/25/2013SE |
| K120357 | Endoscope Reprocessor Oer-MiniFEB · Traditional | Olympus Medical Systems Corp. | 12/20/2012SE |
| K101158 | Lic Instrument Processing SystemFEB · Traditional | Langford IC Systems, Inc. | 05/06/2011SE |
| K103264 | Endoscope Reprocessor Oer-Pro Model Oer-ProFEB · Traditional | Olympus Medical Systems Corporation | 02/23/2011SE |
| K102996 | Medivators Advantage Plus Endoscope ReprocessorFEB · Traditional | Medivators Reprocessing Systems | 01/13/2011SE |
| K092387 | Medivators DSD Edge Endoscope Reprocessing SystemFEB · Traditional | Minntech Corp. | 04/05/2010SE |
| K093106 | Endoscope Reprocessor Oer-ProFEB · Traditional | Olympus Medical Systems Corporation | 02/12/2010SE |
| K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level…FEB · Traditional | Medivators Reprocessing Systems | 02/13/2009SE |
| K082392 | Evotech Endoscope Cleaner and ReprocessorFEB · Special | Advanced Sterilization Products | 11/13/2008SE |
| K063876 | Modular Disinfection System (MDS) for Endoscope ReprocessingFEB · Traditional | Medivators Reprocessing Systems | 06/14/2007SE |
| K061430 | System 83 Plus Miniflex Washer-DisinfectorFEB · Traditional | Custom Ultrasonics | 01/12/2007SE |
| K061899 | Evotech Integrated Endoscope Disinfection SystemFEB · Traditional | Advanced Sterilization Products | 10/26/2006SE |
| K060458 | Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant…FEB · Traditional | Langford IC Systems, Inc. | 10/12/2006SE |
| K040883 | Evotech Integrated Endoscope Disinfection SystemFEB · Traditional | Advanced Sterilization Products | 03/15/2005SE |
| K012309 | Riwo System TraysFEB · Traditional | Richard Wolf Medical Instruments Corp. | 10/19/2001SE |
| K000216 | PSK Endoscope Cleaning SystemFEB · Traditional | Psk Connectors Pty, Ltd. | 05/09/2000SE |
| K973558 | Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)FEB · Traditional | Ultracell Medical Technologies, Inc. | 11/24/1997SE |
| K964871 | Biosearch Syring Flushing/Cleaning Pump for Biosearch Endoscopic InstrumentsFEB · Traditional | Biosearch Medical Products, Inc. | 03/03/1997SE |
| K961607 | Virapump II (Models and Model M)FEB · Traditional | Viatro, Corp. | 12/06/1996SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | Mill-Rose Laboratory | 11/27/1995SE |
| K915402 | EW-10 and EW-20FEB · Traditional | Olympus Corp. | 06/23/1995SN |
| K944776 | Clear Blue Endoscopic Lens Fog Rduction Solution & Cleaning KitFEB · Traditional | Blue Planet Industries, Inc. | 11/01/1994SE |
| K944249 | Auto Suture* Anti-Fog Device**FEB · Traditional | United States Surgical, A Division of Tyco Healthc | 09/20/1994SE |
| K941648 | Blue Planet Lens Fog Reduction & Cleaning KitFEB · Traditional | Blue Planet Industries, Inc. | 05/17/1994SE |
| K941134 | EMC2 Lens Fog Reduction Solution & Cleaning KitFEB · Traditional | H & C Chemical, Inc. | 05/16/1994SE |
| K914524 | Fluid Pump, CP #3FEB · Traditional | United States Endoscopy Group, Inc. | 03/09/1994SE |
| K914145 | DSD-91(TM) Disinfector for Flexible EndoscopesFEB · Traditional | Medivators, Inc. | 02/22/1994SE |
| K915620 | EndowashFEB · Traditional | Novar Medical Industries | 12/02/1993SE |
| K933354 | Hobbs Medical Cleaning BrushFEB · Traditional | Hobbs Medical, Inc. | 10/28/1993SE |
| K932930 | Candela MinibrushFEB · Traditional | Candela Laser Corp. | 10/05/1993SE |
| K924135 | Flexible UreteronephrosocopeFEB · Traditional | Applied Medical Resources | 04/14/1993SE |
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | Keymed, Inc. | 03/29/1993SE |
| K924655 | Cox Disposable Endoscope Cleaning BRUSH(CB-X2)FEB · Traditional | Cox Medical Ent., Inc. | 12/15/1992SE |
| K924103 | Cleaning BrushFEB · Traditional | United States Endoscopy Group, Inc. | 11/16/1992SE |
| K923687 | One Directional Cleaning BrushFEB · Traditional | Endoscopy Support Services, Inc. | 09/23/1992SE |
| K923672 | Cox Disposable Endoscope Cleaning BrushFEB · Traditional | Cox Medical Ent., Inc. | 09/23/1992SE |
| K914442 | Cox Disposable Endoscope Cleaning BrushFEB · Traditional | Cox Medical Ent., Inc. | 10/25/1991SE |
| K901439 | Disp. Endoscope Cleaning Brush - Squeeky CleanFEB · Traditional | Telemed Systems, Inc. | 06/11/1990SE |
| K850268 | Sparco Scope GuardFEB · Traditional | Sparco, Inc. | 04/15/1985SE |
| K840208 | Code 17-ENDOSCOPE DeodorantFEB · Traditional | Knox Laboratories | 07/19/1984SE |
| K830026 | Fiberscope Disinfectant IrrigatorFEB · Traditional | Keymed, Inc. | 01/14/1983SE |
| K820152 | Key Med Leeds Endoscope DisinfectorFEB · Traditional | Keymed, Inc. | 01/29/1982SE |
| K810818 | Key-Med Fibrescope Disinfection TrolleyFEB · Traditional | Keymed, Inc. | 04/08/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1909-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1908-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1907-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1906-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1905-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1904-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1903-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.XXX | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1902-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1901-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1900-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1899-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1898-2026 Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be…Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Olympus Corporation of the Americas | 03/25/2026Open, Classified |
| Z-1613-2026 Class II | Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated… | Olympus Corporation of the Americas | 02/12/2026Open, Classified |
| Z-1612-2026 Class II | Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated… | Olympus Corporation of the Americas | 02/12/2026Open, Classified |
| Z-0874-2026 Class II | Olympus OER-MiniInform existing affected device customers about pertinent Warnings/Cautions, existing recommended… | Aizu Olympus Co., Ltd. | 10/31/2025Open, Classified |
| Z-0873-2026 Class II | Olympus OER-ProInform existing affected device customers about pertinent Warnings/Cautions, existing recommended… | Aizu Olympus Co., Ltd. | 10/31/2025Open, Classified |
| Z-0872-2026 Class II | Olympus OER-EliteInform existing affected device customers about pertinent Warnings/Cautions, existing recommended… | Aizu Olympus Co., Ltd. | 10/31/2025Open, Classified |
| Z-2539-2024 Class II | Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the…IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup… | Steris Corporation | 06/13/2024Open, Classified |
| Z-2538-2024 Class II | Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the…IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup… | Steris Corporation | 06/13/2024Open, Classified |
| Z-2537-2024 Class II | Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the…IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup… | Steris Corporation | 06/13/2024Open, Classified |
| Z-2536-2024 Class II | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface…IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup… | Steris Corporation | 06/13/2024Open, Classified |
| Z-1009-2024 Class II | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with…Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for… | Olympus Corporation of the Americas | 01/16/2024Open, Classified |
| Z-0617-2024 Class II | Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru…Identification label on affected hookups could become illegible over time due to the label's ink coming off.… | Steris Corporation | 11/13/2023Open, Classified |
| Z-2447-2023 Class II | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC…The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the… | Olympus Corporation of the Americas | 07/12/2023Open, Classified |
| Z-2344-2023 Class II | Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection…Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer… | Olympus Corporation of the Americas | 05/26/2023Open, Classified |
| Z-2343-2023 Class II | Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection…Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer… | Olympus Corporation of the Americas | 05/26/2023Open, Classified |
| Z-2342-2023 Class II | Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of…Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer… | Olympus Corporation of the Americas | 05/26/2023Open, Classified |
| Z-0638-2022 Class II | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat…The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is… | Olympus Corporation of the Americas | 12/13/2021Terminated |
| Z-0458-2021 Class III | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid…Potential for cleaning solution intrusion into endoscope | Steris Corporation | 10/07/2020Terminated |
| Z-0965-2017 Class II | EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System… | Advanced Sterilization Products | 09/27/2016Terminated |
| Z-0138-2017 Class II | OER-Pro Endoscope Reprocessor, Endoscope washer/disinfectorNew warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an… | Olympus Corporation of the Americas | 06/23/2016Terminated |
| Z-1715-2015 Class II | EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR)… | Advanced Sterilization Products | 05/11/2015Terminated |
| Z-1714-2015 Class II | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR)… | Advanced Sterilization Products | 05/11/2015Terminated |
| Z-1150-2013 Class II | EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically…Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR)… | Advanced Sterilization Products | 03/28/2013Terminated |
| Z-1123-2013 Class II | EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically…Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured… | Advanced Sterilization Products | 03/22/2013Terminated |
| Z-2213-2010 | DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup…The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope… | Minntech Corp | 06/15/2010Terminated |
| Z-0281-2009 | ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer…Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP… | Advanced Sterilization Products | 09/11/2008Terminated |
| Z-1369-2008 | EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with…Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the… | Advanced Sterilization Products | 02/13/2008Terminated |
| Z-1368-2008 | EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high…Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the… | Advanced Sterilization Products | 02/13/2008Terminated |
| Z-0770-2007 | 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.The device was marketed without a 510k | Custom Ultrasonics, Inc. | 12/12/2005Terminated |