FDA 510(k) Applications for Medical Device Product Code "FEB"
(Accessories, Cleaning, For Endoscope)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K140977 | ADVANCED STERILIZATION PRODUCTS | EVOTECH ECR | 12/22/2014 |
| K082392 | ADVANCED STERILIZATION PRODUCTS | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR | 11/13/2008 |
| K040883 | ADVANCED STERILIZATION PRODUCTS | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | 03/15/2005 |
| K061899 | ADVANCED STERILIZATION PRODUCTS | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | 10/26/2006 |
| K181472 | Advanced Sterilization Products (ASP) | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | 04/23/2019 |
| K152189 | Advanced Sterilization Products (ASP) | EVOTECH ECR | 07/20/2016 |
| K964871 | BIOSEARCH MEDICAL PRODUCTS, INC. | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | 03/03/1997 |
| K122172 | CUSTOM ULTRASONICS | SYSTEM 83 PLUS | 01/25/2013 |
| K061430 | CUSTOM ULTRASONICS | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | 01/12/2007 |
| K162120 | Custom Ultrasonics Inc. | Scope-Assist Flushing Sink | 04/28/2017 |
| K173590 | Custom Ultrasonics, Inc. | System 83 Plus Washer/Disinfector | 03/30/2020 |
| K101158 | LANGFORD IC SYSTEMS, INC. | LIC INSTRUMENT PROCESSING SYSTEM | 05/06/2011 |
| K060458 | LANGFORD IC SYSTEMS, INC. | MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR | 10/12/2006 |
| K213833 | Medivators Inc | SCOPE BUDDY PLUS Endoscope Flushing Aid | 01/14/2022 |
| K172677 | Medivators Inc. | Advantage Plus Pass-Thru | 12/19/2017 |
| K162128 | MEDIVATORS INC. | Scope Buddy Plus Endoscope Flushing Aid | 12/21/2016 |
| K082988 | MEDIVATORS REPROCESSING SYSTEMS | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT | 02/13/2009 |
| K102996 | MEDIVATORS REPROCESSING SYSTEMS | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR | 01/13/2011 |
| K063876 | MEDIVATORS REPROCESSING SYSTEMS | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING | 06/14/2007 |
| K092387 | MINNTECH CORP. | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | 04/05/2010 |
| DEN240018 | Nanosonics Limited | CORIS System | 03/19/2025 |
| K190969 | Olympus Medical Systems Corp. | ENDOSCOPE REPROCESSOR OER-Elite | 07/09/2019 |
| K201920 | Olympus Medical Systems Corp. | Endoscope Reprocessor OER-Elite | 09/01/2020 |
| K120357 | OLYMPUS MEDICAL SYSTEMS CORP. | ENDOSCOPE REPROCESSOR OER-MINI | 12/20/2012 |
| K093106 | OLYMPUS MEDICAL SYSTEMS CORPORATION | ENDOSCOPE REPROCESSOR OER-PRO | 02/12/2010 |
| K103264 | OLYMPUS MEDICAL SYSTEMS CORPORATION | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | 02/23/2011 |
| K000216 | PSK CONNECTORS PTY LTD | PSK ENDOSCOPE CLEANING SYSTEM | 05/09/2000 |
| K012309 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | RIWO SYSTEM TRAYS | 10/19/2001 |
| K181865 | STERIS Corporation | Acu-sInQ Complete Endoscope Cleaning Aid System | 12/14/2018 |
| K243433 | STERIS Corporation | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | 12/02/2024 |
| K230930 | STERIS Corporation | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | 06/30/2023 |
| K973558 | ULTRACELL MEDICAL TECHNOLOGIES, INC. | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | 11/24/1997 |
| K961607 | VIATRO, CORP. | VIRAPUMP II (MODELS AND MODEL M) | 12/06/1996 |
| K241168 | Wassenburg Medical, Inc. | System 83 Revolve Endoscope Washer/Disinfector | 12/19/2024 |
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