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 |
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 |
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 |