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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: GEI FDA class 2

    Electrosurgical, Cutting & Coagulation & Accessories

    General, Plastic Surgery

    View full classification →

    The Electrosurgical, Cutting and Coagulation device and its accessories (product code GEI) are powered surgical instruments used to cut tissue and achieve hemostasis through the application of high-frequency electrical current during general and plastic surgery procedures. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 878.4400 in the General, Plastic Surgery specialty (SU), it is eligible for third-party review. Reusable versions with specific design features must include validated reprocessing instructions and reprocessing validation data in the 510(k) submission, as referenced in 82 FR 26807.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
    CoolSeal Generator® (CSL-200-90)
    NEUROMARK System (NMK00301)
    LAP-iX2N
    OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
    MILAN System
    Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
    ENTire IRE System
    VIVA combo RF System
    LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
    RhinAer+ Stylus
    ARION ARC System
    Ascblue (8010)
    Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
    SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
    Prana System
    FLOW FLEXTEND Wand (72290039)
    AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
    LYNX COBLATION Laryngeal Wand (72290254)
    BTL-785NEH
    POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
    SP Electrocautery Device (SP20)
    CURIS II RF Generator (REF 360100-05)
    Dermatrix Duo
    ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
    InbellaIgnite RF System
    Reusable 3 Button Fingerswitch Wand
    Ignite RF System
    ENTire IRE System
    Boston iFace (Boston iFace)
    MOVIVA® Hybrid Ablation Probe
    F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
    TS-RF Generator (STS10)
    Venus Nova (FP-2001)
    Voyant® Open Fusion Device (EB240/Open Fusion)
    Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
    PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
    ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
    Coolfase
    InbellaMulti System
    Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
    Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
    E Blator
    NEW DOUBLO 2.0
    Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
    Legend X Platform
    PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
    AGNES Ultra
    Erbe ESU Model VIO® 3n with Accessories
    Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

    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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