BEUDAMED
    Product Code: FBN FDA class 2 21 CFR 876.1500

    Choledochoscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    The Choledochoscope and Accessories (Flexible/Rigid) (product code FBN) is an endoscopic instrument used to examine and perform procedures within the bile ducts. 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. For reusable flexible endoscopes of this type, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

    View on FDA
    510(k)s
    39
    FEI Numbers
    43
    Registration Numbers
    43
    Unique Applicants
    26
    Years Active
    48

    Basic Information

    Product Code
    FBN
    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 examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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 39 510(k) clearances via K numbers.

    K Number Device Name
    K243535 Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
    K241444 Biliary Pancreaticobiliary Scope System
    K233752 Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps
    K231497 Choledochoscope System
    K231105 Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
    K223741 Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
    K222261 Flexible Video-Choledochoscope System
    K221784 Single-use Video Pancreaticobiliary Scope, PB Digital Controller
    K200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
    K183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
    K181439 SpyGlass DS and DS II Direct Visualization System
    K161147 EndoCure Model EUR078A
    K142922 SpyGlass DS Direct Visualization System
    K113120 CHF-Y0005
    K093507 OLYMPUS CHF TYPE Y0003
    K081456 OLYMPUS CHF TYPE V
    K082576 XCHF-T160 VIDEOSCOPE
    K080586 OLYMPUS XCHF TYPE B180Y1
    K060269 ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
    K051886 OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
    K972926 MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
    K971977 KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
    K962172 FLEXIBLE MINI-FIBERSCOPES
    K944473 XCHF-33 CHOLEDOCHOFIBERSCOPE
    K953286 FCP-9P, FIBER CHOLEDOCHOSCOPE
    K951191 FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
    K942112 KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
    K933906 CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
    K935834 TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
    K931382 11274 AC FLEXINBLE CHOLEDOCHOSCOPE
    K924228 OMEGASCOPE
    K920224 DOSCOPE AND ACESSORIES
    K915681 CHOLEDOCHOSCOPE
    K912120 URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
    K911480 FLEXIBLE CHOLEDOCHOSCOPE
    K904799 CHF-B20 CHOLEDOCHOSCOPE
    K901010 FLEXIBLE CHOLEDOCHOSCOPE
    K821974 PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
    K771367 CHOLEDOCHOSCOPE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.