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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: HCG FDA class 2

    Device, Neurovascular Embolization

    Neurology

    View full classification →

    The Neurovascular Embolization Device is an implanted endovascular device used to deliberately occlude or reduce blood flow to intracranial vascular lesions such as arteriovenous malformations, tumors, or aneurysms, by delivering embolic material through a catheter. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is HCG under regulation 21 CFR 882.5950 in the Neurology specialty. The implant flag is active for this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Numen™ Coil Embolization System; NumenFR™ Detachment System
    Optima Coil System (OptiBlock Line Extension)
    Target Detachable Coils
    Numen Coil Embolization System; NumenFR Detachment System
    Axium Detachable Coil; Axium Prime Detachable Coil
    Penumbra LP Coil System
    Target Tetra Detachable Coils
    Optima Coil System
    CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
    InZone Detachment System
    Numen Coil Embolization System; NumenFR Detachment System
    Axium Detachable Coil; Axium Prime Detachable Coil
    MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
    i-ED COIL System
    i-ED COIL
    Optima Coil System
    Penumbra LP Coil System
    Spartan eCoil System
    Wallaby Avenir Coil System
    Penumbra Coil 400, Ruby Coil System, POD System
    Optima Coil System
    GALAXY G3 Mini Microcoil Delivery System
    POD Packing Coil
    MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
    V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
    Axium Prime Detachable Coil System
    MicroPlex Coil System (MCS) - HyperSoft 3D
    HydroCoil Embolic System (HES)
    Target Detachable Coils
    Target Detachable Coils
    Penumbra Smart Coil
    InZone Detachment System
    MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
    Axium Detachable Coil System
    Barricade Embolization Coil System
    Penumbra Smart Coil
    MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
    Penumbra Smart Coil
    CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
    Barricade Embolization Coil System
    POD SYSTEM
    BARRICADE EMBOLIZATION COIL SYSTEM
    AXIUM DETACHABLE COIL SYSTEM
    MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
    BARRICADE EMBOLIZATION COIL SYSTEM
    MICROPLEX COIL SYSTEM (MCS)
    MICROPLEX COIL SYSTEM (MCS), VFC
    BARRICADE EMBOLIZATION COIL SYSTEM
    BARRICADE EMBOLIZATION COIL SYSTEM
    VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM

    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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