Product Code: FEB
FDA class 2
21 CFR 876.1500
Accessories, Cleaning, For Endoscope
Gastroenterology, Urology
The Cleaning Accessories for Endoscope (product code FEB) are tools and supplies used in the manual cleaning and reprocessing of endoscopes to remove biological material and prepare the instrument for disinfection or sterilization. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).
510(k)s
58
FEI Numbers
26
Registration Numbers
26
Unique Applicants
39
Years Active
44
Basic Information
- Product Code
- FEB
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
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).
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 58 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240018 | CORIS System | Mar 19, 2025 | Unknown | Nanosonics Limited |
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | Dec 19, 2024 | Substantially Equivalent | Wassenburg Medical, Inc. |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | Dec 02, 2024 | Substantially Equivalent | STERIS Corporation |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | Jun 30, 2023 | Substantially Equivalent | STERIS Corporation |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Jan 14, 2022 | Substantially Equivalent | Medivators Inc |
| K201920 | Endoscope Reprocessor OER-Elite | Sep 01, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K173590 | System 83 Plus Washer/Disinfector | Mar 30, 2020 | Substantially Equivalent | Custom Ultrasonics, Inc. |
| K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Jul 09, 2019 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Apr 23, 2019 | Substantially Equivalent | Advanced Sterilization Products (ASP) |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | Dec 14, 2018 | Substantially Equivalent | STERIS Corporation |
| K172677 | Advantage Plus Pass-Thru | Dec 19, 2017 | Substantially Equivalent | Medivators Inc. |
| K162120 | Scope-Assist Flushing Sink | Apr 28, 2017 | Substantially Equivalent | Custom Ultrasonics Inc. |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | Dec 21, 2016 | Substantially Equivalent | MEDIVATORS INC. |
| K152189 | EVOTECH ECR | Jul 20, 2016 | Substantially Equivalent | Advanced Sterilization Products (ASP) |
| K140977 | EVOTECH ECR | Dec 22, 2014 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K122172 | SYSTEM 83 PLUS | Jan 25, 2013 | Substantially Equivalent | CUSTOM ULTRASONICS |
| K120357 | ENDOSCOPE REPROCESSOR OER-MINI | Dec 20, 2012 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORP. |
| K101158 | LIC INSTRUMENT PROCESSING SYSTEM | May 06, 2011 | Substantially Equivalent | LANGFORD IC SYSTEMS, INC. |
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | Feb 23, 2011 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K102996 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR | Jan 13, 2011 | Substantially Equivalent | MEDIVATORS REPROCESSING SYSTEMS |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | Apr 05, 2010 | Substantially Equivalent | MINNTECH CORP. |
| K093106 | ENDOSCOPE REPROCESSOR OER-PRO | Feb 12, 2010 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K082988 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT | Feb 13, 2009 | Substantially Equivalent | MEDIVATORS REPROCESSING SYSTEMS |
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR | Nov 13, 2008 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K063876 | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING | Jun 14, 2007 | Substantially Equivalent | MEDIVATORS REPROCESSING SYSTEMS |
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | Jan 12, 2007 | Substantially Equivalent | CUSTOM ULTRASONICS |
| K061899 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | Oct 26, 2006 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K060458 | MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR | Oct 12, 2006 | Substantially Equivalent | LANGFORD IC SYSTEMS, INC. |
| K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | Mar 15, 2005 | Substantially Equivalent | ADVANCED STERILIZATION PRODUCTS |
| K012309 | RIWO SYSTEM TRAYS | Oct 19, 2001 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K000216 | PSK ENDOSCOPE CLEANING SYSTEM | May 09, 2000 | Substantially Equivalent | PSK CONNECTORS PTY LTD |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | Nov 24, 1997 | Substantially Equivalent | ULTRACELL MEDICAL TECHNOLOGIES, INC. |
| K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | Mar 03, 1997 | Substantially Equivalent | BIOSEARCH MEDICAL PRODUCTS, INC. |
| K961607 | VIRAPUMP II (MODELS AND MODEL M) | Dec 06, 1996 | Substantially Equivalent | VIATRO, CORP. |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | Nov 27, 1995 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K915402 | EW-10 AND EW-20 | Jun 23, 1995 | Substantially Equivalent for Some Indications | OLYMPUS CORP. |
| K944776 | CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT | Nov 01, 1994 | Substantially Equivalent | BLUE PLANET INDUSTRIES, INC. |
| K944249 | AUTO SUTURE* ANTI-FOG DEVICE** | Sep 20, 1994 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K941648 | BLUE PLANET LENS FOG REDUCTION & CLEANING KIT | May 17, 1994 | Substantially Equivalent | BLUE PLANET INDUSTRIES, INC. |
| K941134 | EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT | May 16, 1994 | Substantially Equivalent | H&C CHEMICAL, INC. |
| K914524 | FLUID PUMP, CP #3 | Mar 09, 1994 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Feb 22, 1994 | Substantially Equivalent | MEDIVATORS, INC. |
| K915620 | ENDOWASH | Dec 02, 1993 | Substantially Equivalent | NOVAR MEDICAL INDUSTRIES |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | Oct 28, 1993 | Substantially Equivalent | HOBBS MEDICAL, INC. |
| K932930 | CANDELA MINIBRUSH | Oct 05, 1993 | Substantially Equivalent | CANDELA LASER CORP. |
| K924135 | FLEXIBLE URETERONEPHROSOCOPE | Apr 14, 1993 | Substantially Equivalent | APPLIED MEDICAL RESOURCES |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Mar 29, 1993 | Substantially Equivalent | KEYMED, INC. |
| K924655 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) | Dec 15, 1992 | Substantially Equivalent | COX MEDICAL ENT., INC. |
| K924103 | CLEANING BRUSH | Nov 16, 1992 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K923687 | ONE DIRECTIONAL CLEANING BRUSH | Sep 23, 1992 | Substantially Equivalent | ENDOSCOPY SUPPORT SERVICES, INC. |
| K923672 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | Sep 23, 1992 | Substantially Equivalent | COX MEDICAL ENT., INC. |
| K914442 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | Oct 25, 1991 | Substantially Equivalent | COX MEDICAL ENT., INC. |
| K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN | Jun 11, 1990 | Substantially Equivalent | TELEMED SYSTEMS, INC. |
| K850268 | SPARCO SCOPE GUARD | Apr 15, 1985 | Substantially Equivalent | SPARCO, INC. |
| K840208 | CODE 17-ENDOSCOPE DEODORANT | Jul 19, 1984 | Substantially Equivalent | KNOX LABORATORIES |
| K830026 | FIBERSCOPE DISINFECTANT IRRIGATOR | Jan 14, 1983 | Substantially Equivalent | KEYMED, INC. |
| K820152 | KEY MED LEEDS ENDOSCOPE DISINFECTOR | Jan 29, 1982 | Substantially Equivalent | KEYMED, INC. |
| K810818 | KEY-MED FIBRESCOPE DISINFECTION TROLLEY | Apr 08, 1981 | Substantially Equivalent | KEYMED, INC. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.