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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: FDS FDA class 2

    Gastroscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    View full classification →

    The Gastroscope and Accessories (Flexible/Rigid) (product code FDS) is an endoscopic instrument used to examine or perform procedures in the stomach, including biopsy, polypectomy, and hemostasis. 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 Distal Cap
    EvoEndo Single-Use Endoscopy System
    FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
    Endoscopic Distal Attachment (AF-D series)
    Disposable Distal Attachment D-201 Series
    PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
    Hood (DH-083ST)
    FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
    EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
    Ambu® aScope™ Gastro Large; Ambu® aBox™ 2
    Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
    Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
    FUJIFILM Endoscope Model EI-740D/S
    EvoEndo Single-Use Endoscopy System
    Ambu® aScope™ Gastro, Ambu® aBox™2
    PENTAX Medical Video Upper GI Scopes EG17-J10
    Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
    Pathfinder Endoscope Cap
    PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
    Endoscope Model EI-740D/S
    Endofresh Digestive Endoscopy System
    Fujifilm Ultrasonic Processor
    FUJIFILM Distal Cap Models 33-40
    PENTAX Medical Video Upper GI Scopes (EG Family)
    FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
    FUJIFILM Endoscope Model EG-740N
    FUJIFILM Endoscope Model EG-530N
    PENTAX Video Upper G.I. Scope EG34-i10
    FUJIFILM 600 Series Endoscope EG-600WR v2
    FUJIFILM Ultrasonic Endoscope
    Visura Technologies TEECAD System
    SB Soft Hood - Straight type, SB Soft Hood - Undercut type
    FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
    FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
    Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
    Fuse Gastroscopy System
    EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
    GIS ENDOSCOPIC OPTICAL LENS
    PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
    PEERSCOPE SYSTEM
    FOREIGN BODY HOOD
    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
    FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
    CLEARPATH UPPER GI
    FUJINON ULTRASONIC PROCESSOR
    CLEARPATH UGI
    FUJINON MODEL EG-530N TRANS NASAL INSERTION
    FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
    KARL STORZ VIDEO GASTROSCOPES
    FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5

    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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