Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PUPEndoscope Maintenance System2Product Code
- FEBAccessories, Cleaning, For Endoscope2Product Code
- K241168System 83 Revolve Endoscope Washer/Disinfector2Cleared 510(K)
- K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing System2Cleared 510(K)
- K213833SCOPE BUDDY PLUS Endoscope Flushing Aid2Cleared 510(K)
- K201920Endoscope Reprocessor OER-Elite2Cleared 510(K)
- K173590System 83 Plus Washer/Disinfector2Cleared 510(K)
- K190969ENDOSCOPE REPROCESSOR OER-Elite2Cleared 510(K)
- K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor2Cleared 510(K)
- K181865Acu-sInQ Complete Endoscope Cleaning Aid System2Cleared 510(K)
- K172677Advantage Plus Pass-Thru2Cleared 510(K)
- K162120Scope-Assist Flushing Sink2Cleared 510(K)
- K162128Scope Buddy Plus Endoscope Flushing Aid2Cleared 510(K)
- K152189EVOTECH ECR2Cleared 510(K)
- K140977EVOTECH ECR2Cleared 510(K)
- K122172SYSTEM 83 PLUS2Cleared 510(K)
- K120357ENDOSCOPE REPROCESSOR OER-MINI2Cleared 510(K)
- K101158LIC INSTRUMENT PROCESSING SYSTEM2Cleared 510(K)
- K103264ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO2Cleared 510(K)
- K102996MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR2Cleared 510(K)
- K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM2Cleared 510(K)
- K093106ENDOSCOPE REPROCESSOR OER-PRO2Cleared 510(K)
- K082988MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT2Cleared 510(K)
- K082392EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR2Cleared 510(K)
- K063876MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING2Cleared 510(K)
- K061430SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR2Cleared 510(K)
- K061899EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM2Cleared 510(K)
- K060458MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR2Cleared 510(K)
- K040883EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM2Cleared 510(K)
- K012309RIWO SYSTEM TRAYS2Cleared 510(K)
- K000216PSK ENDOSCOPE CLEANING SYSTEM2Cleared 510(K)
- K973558VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)2Cleared 510(K)
- K964871BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K961607VIRAPUMP II (MODELS AND MODEL M)2Cleared 510(K)
- K954745MILL-ROSE RIGID SCOPE CLEANING BRUSHES2Cleared 510(K)
- K915402EW-10 AND EW-202Cleared 510(K)
- K944776CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT2Cleared 510(K)
- K944249AUTO SUTURE* ANTI-FOG DEVICE**2Cleared 510(K)
- K941648BLUE PLANET LENS FOG REDUCTION & CLEANING KIT2Cleared 510(K)
- K941134EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT2Cleared 510(K)
- K914524FLUID PUMP, CP #32Cleared 510(K)
- K914145DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES2Cleared 510(K)
- K915620ENDOWASH2Cleared 510(K)
- K933354HOBBS MEDICAL CLEANING BRUSH2Cleared 510(K)
- K932930CANDELA MINIBRUSH2Cleared 510(K)
- K924135FLEXIBLE URETERONEPHROSOCOPE2Cleared 510(K)
- K921179OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-202Cleared 510(K)
- K924655COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)2Cleared 510(K)
- K924103CLEANING BRUSH2Cleared 510(K)
- K923687ONE DIRECTIONAL CLEANING BRUSH2Cleared 510(K)
- K923672COX DISPOSABLE ENDOSCOPE CLEANING BRUSH2Cleared 510(K)
- K914442COX DISPOSABLE ENDOSCOPE CLEANING BRUSH2Cleared 510(K)
- K901439DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN2Cleared 510(K)
- K850268SPARCO SCOPE GUARD2Cleared 510(K)
- K840208CODE 17-ENDOSCOPE DEODORANT2Cleared 510(K)
- K830026FIBERSCOPE DISINFECTANT IRRIGATOR2Cleared 510(K)
- K820152KEY MED LEEDS ENDOSCOPE DISINFECTOR2Cleared 510(K)
- K810818KEY-MED FIBRESCOPE DISINFECTION TROLLEY2Cleared 510(K)
- NVEWasher, Cleaner, Automated, Endoscope2Product Code
- NZAAccessories, Germicide, Cleaning, For Endoscopes2Product Code
- OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist2Product Code
- PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid2Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
EVOTECH ECR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K152189
- 510(k) Type
- Traditional
- Applicant
- Advanced Sterilization Products (ASP)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/20/2016
- Days to Decision
- 350 days
- Submission Type
- Summary