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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: FAJ FDA class 2

    Cystoscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    View full classification →

    The Cystoscope and Accessories (Flexible/Rigid) (product code FAJ) is an endoscopic instrument used to examine and perform procedures within the urinary tract, including the bladder and urethra. 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).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
    Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
    Uro-G HD Cystoscope (1520)
    Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2
    Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance
    LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)
    Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
    Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
    BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
    Uro-G HD Flexible Cystoscope
    Cystoscope System
    VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
    WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
    Endo SmartCap
    CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
    OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
    Single-Use Flexible Cystoscope
    Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
    Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
    WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
    KARL STORZ Flexible HD Cysto-Urethroscope System
    LUMINELLE DTx System
    Uro-G Cystoscope
    Flexible Video Cysto-Urethroscope (C-view)
    Ambu aScope 4 Cysto
    Flexible HD Cysto-Urethroscope System
    Uro-N Cystoscope
    Flexible HD Cysto-Urethroscope System
    Luminelle DTx Hysteroscopy System
    Uro-V Cystoscope
    Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
    Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
    Ambu USR, Ambu M
    CytoSure Urinary Access System
    ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
    CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
    ENDO SMARTCAP
    MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
    VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
    FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
    MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
    FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
    STRYKER FLEXIBLE CYSTONEPHROSCOPE
    NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
    ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
    VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
    SOHNIKS
    ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
    ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
    VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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