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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: FDF FDA class 2

    Colonoscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    View full classification →

    The Colonoscope and Accessories (Flexible/Rigid) (product code FDF) is an endoscopic instrument used to examine or perform procedures in the colon or rectum, including polypectomy, biopsy, and therapeutic interventions. 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
    Disposable Endoscopic Distal Attachments
    Disposable Distal End Tape Hood
    ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
    FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
    Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
    PENTAX Medical Video Colonoscope (EC38-i20cWL)
    GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
    Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
    GripTract-GI Endoscopic Tissue Manipulator
    Pure-Vu EVS System
    Ambu® aScope™ Colon; Ambu® aBox™ 2
    FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
    Aer-O-Scope Colonoscope System
    DiLumen C1, EZ1 and Tool Mount
    Insufflation Retention Device
    G-EYE System
    Balloon Dilatation Catheter
    Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
    Pure-Vu EVS System
    DiLumen C2 and Tool Mount
    Pure Vu System
    DiLumen Endolumenal Interventional Platform (DiLumen)
    G-EYE System
    Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
    G-EYE System
    Endotics
    FUJIFILM Endoscope Model EC-760Z-V/L
    Pure Vu System
    FUJIFILM Endoscope Model EC-760S-V/L
    PENTAX Video Colonoscopes (EC Family)
    DiLumen Endolumenal Interventional Platform
    PENTAX Medical Video Colonoscope EC34-i10T Series
    Pure Vu System
    DiLumen C2; DiLumen Tool Mount
    FUJIFILM Endoscope Models EC-600HL and EC-600LS
    Focus Cap
    invendoscopy E210 System
    Pure-Vu System
    Medrobotics Flex Robotic System
    Flex Robotic System and Flex Colorectal Drive
    Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
    DiLumen Endolumenal Interventional Platform
    Fujifilm Endoscope Models EC-600HL and EC-600LS
    Pure Vu
    invendoscopy E200 System
    Aer-O-Scope Colonoscope System
    Third Eye Panoramic Auxiliary Endoscopy System - Resposable
    Fujifilm Video Colonoscope Model EC-600WL V2
    Balloon controller PB-30
    FUJIFILM Endoscope Models EC-600HL and EC-600LS

    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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