BEUDAMED
    Product Code: ODC FDA class 2 21 CFR 876.1500

    Endoscope Channel Accessory

    Gastroenterology, Urology

    The Endoscope Channel Accessory (product code ODC) is a gastroenterology and urology accessory designed to give the endoscope's working channel additional or improved functionality, such as modified flow characteristics, additional ports, or enhanced instrument passage capabilities. These accessories expand the utility of the endoscope for a variety of diagnostic and therapeutic applications. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    72
    FEI Numbers
    80
    Registration Numbers
    80
    Unique Applicants
    50
    Years Active
    46

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    Basic Information

    Product Code
    ODC
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To give the endoscope channel additional or improved functionality.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 72 510(k) clearances via K numbers.

    K Number Device Name
    K252933 DYNE PORT
    K250145 Biopsy Port Adapter
    K252910 Orca Air/Water and Suction Valves
    K250949 Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
    K250732 Disposable Endoscopy Valve Set
    K241842 Luer-Split MAJ-2092
    K250140 Defendo Fujifilm 700 Single Use Cleaning Adapter
    K243075 Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
    K242742 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
    K241285 Disposable Endoscope Valves Set (AF series)
    K232067 Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
    K232327 Endorail
    K240352 Defendo Single Use Cleaning Adapter for Olympus Endoscopes
    K232004 Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
    K240098 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
    K232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
    K232249 PENTAX Medical Gas/Water Feeding Valve OE-B14
    K232244 Disposable Endoscope Valves System
    K222499 Disposable Endoscope Valves Kit
    K232951 BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
    K232118 ANDORATE® Valve Kit
    K220884 Disposable Endoscope Valve Sets
    K222980 Pentax Medical Valve Set
    K221331 Disposable Endoscope Valves System
    K220210 Disposable Endoscopy Adapter Set
    K221264 FROG Forceps Valve (VAL1-F1-100)
    K213483 SnapLoc Wire Lock
    K220247 Guidewire Locking Device
    K211814 Wellead Endoscopic Seal
    K213095 andorate Suction Valve, andorate Air/Water Valve
    K210625 JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
    K210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
    K210353 AutoCap RX
    K202104 BioGuard EUS Air/Water and Suction Valves
    K203630 BioGuard Air/Water and Suction Valves
    K200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
    K202237 Locking device
    K200495 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
    K200481 Andorate Biopsy Valve, Andorate Biopsy Irrigator
    K192048 Single Use Endoscope Valves Set
    K192258 Disposable Valve Sets
    K192059 Bio Guard Air/Water & Suction Valves
    K191231 Andorate Auxiliary Water Connector, Andorate Valves Set
    K190164 CleverLock Guidewire Locking Device and Biopsy Cap
    K181712 San Antonio Stopcock
    K173105 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
    K162142 Accessory Irrigation Adapter
    K160403 SmartStart Air/Water and Suction Valves
    K151714 Disposable Endoscope Valves Set A
    K151345 BioGuard Air/Water Valve, BioGuard Suction Valve
    K112698 CONCENTRIC BALLOON GOOGLE
    K112106 NAVIAID ICVI-F,S,B,R DEVICE
    K103155 SUMO ACCESS AND TISSUE RESECTION SYSTEM
    K111760 NAVIAID(TM) BGC DEVICE
    K110291 NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
    K110088 DEFENDO Y-OPSY IRRIGATOR
    K102581 DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
    K102409 DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
    K101094 CLEARJET
    K093329 SCOPE INTRODUCER MODEL 7400
    K090851 DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
    K080764 SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
    K073484 ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432
    K073507 ANCHORAGE ACCESS KIT
    K024301 LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
    K010610 RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
    K970110 BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
    K920030 SURESEAL ENDOSCOPIC VALVE
    K915719 ANGEION ENDOSCOPIC VALVE SEAL
    K884097 MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES
    K862107 PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR
    K800962 M.R. ASSOC. WASHING TUBE/MEASURING TUBE

    FEI Numbers

    This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.