BEUDAMED
    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: LQR FDA class 2

    Dislodger, Stone, Biliary

    Gastroenterology, Urology

    View full classification →

    The Biliary Stone Dislodger is an endoscopic device used to dislodge or reposition bile duct stones to facilitate their extraction or passage, typically used in conjunction with other biliary stone removal instruments during endoscopic retrograde cholangiopancreatography (ERCP). It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LQR, regulated under 21 CFR 876.5010, within the Gastroenterology and Urology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
    Extraction Basket
    Single-use Extraction Baskets
    Stone Extraction Baskets
    SpyGlass Discover Retrieval Basket
    Disposable Stone Extraction basket
    Stonetome Stone Removal Device
    Wilson-Cook Mini Basket
    Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
    Nathanson Transcystic Bile Duct Stone Exploration Pack
    Strange Bile Duct Stone Exploration Set
    Wittich Nitinol Stone Basket
    Single Use Retrieval Nitinol Basket V
    NCompass Nitinol Stone Extractors
    RSH BILIARY STONE REMOVAL DEVICE
    SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
    COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
    SPYCATCH STONE RETRIEVAL BASKET
    LEMAITRE BILIARY CATHETER
    KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
    ENDOSCOPIC BILIARY CATHETER
    LSVP INTERNATIONAL GRASPING FORCEPS
    GIP/MED-GLOBE STONE EXTRACTOR BASKETS
    HATCHER STONE-EMBOLIS EXTRACTOR
    MICROVASIVE INSURG FLAT WIRE BASKETS
    MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
    HELI-TECH RETRIEVAL BASKET
    BILIARY STONE DISLODGER
    OVER THE WIRE STONE BASKET
    GLASSMAN STONE EXTRACTION SET
    WITTICH NITINOL STONE BASKET
    COPE NITINOL STONE BASKET
    WILTEK BALLOON STONE EXTRACTOR
    WILTEK STONE EXTRACTOR
    TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)
    HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER
    ENDOSOPIC STENE MANIPULATING BALLOON

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump