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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: FFL FDA class 2

    Dislodger, Stone, Basket, Ureteral, Metal

    Gastroenterology, Urology

    View full classification →

    The Metal Ureteral Stone Basket Dislodger is a rigid or semi-rigid wire basket device inserted through a ureteroscope or cystoscope to capture, dislodge, and retrieve stones from the ureter. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FFL, regulated under 21 CFR 876.4680, within the Gastroenterology, Urology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Peralta Stone Removal Catheter
    Accordion Piccolo Stone Management Device
    ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
    COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
    ACCORDION
    REPROCESSED STONE RETRIEVAL BASKETS
    AMS FOREIGN BODY EXTRATOR
    COMEG ENDOSCOPY GRASPING FORCEPS
    OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
    BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
    OLYMPUS FG-45/46-1 GRASPING FORCEPS
    FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC
    METAL URETERAL BASKET STONE DISLODGER
    METEL URETERAL BASKET STONE DISLODGER
    STONE EXTRACTOR, GRASPING FORCEPS
    STONE EXTRACTOR
    ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
    HELICAL STONE/FLATWIRE STONE BASKETS
    METAL URETERAL BASKET STONE DISLODGER
    STONE RETRIEVAL BASKET
    DISLODGER, STONE, BASKET, URETERAL, METAL
    LOOP RETRIEVER
    ENDOSCOPIC RETRIEVAL BASKET
    BARD 4-WIRE URETEROSCOPIC STONE
    STONE BASKET
    LOOP RETRIEVER
    PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
    METAL URETERAL BASKET STONE DISLODGER
    METAL URETERAL BASKET STONE DISLODGER
    UROLOGICAL STONE BASKET
    CANDELA STONE BASKETS
    VAN-TEC REUSABLE HELICAL STONE BASKET
    HELICAL STONE BASKET (DISPOSABLE)
    VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
    VAN-TEC POSITIVE OPEN SEGURA BASKET
    SEGURA DRETLER BASKET
    PENN 3-RING HANDLE
    4-WIRE (CARSON) STONE EXTRACTOR
    DUTHOY STONE BASKET
    VAN-TEC DEFLECTING GRASPING FORCEPS
    DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER
    VAN-TEC DEFLECTING LOOP RETRIEVER
    VAN-TEC DEFLECTING ROTATING SEGURA BASKET
    ANGIOMED URETERAL STONE DISLODGERS
    URETERAL STONE DISLODGER
    WILSON-COOK STONE EXTRACTOR
    URETERAL DILATOR & URETERAL STONE DISLODGER
    SEGURA BASKET
    BALLOON DILATION HELICAL STONE EXTRACT
    GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET

    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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