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: 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
    DENSITY; DENZA; DENSITY Noir
    HybridAPC probe
    Electrosurgical Pads
    EndyMed PRO MAX
    DELPHI System
    gi2000 Electrosurgical Generator
    Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
    NEUROMARK System (NMK00301)
    BLESSING System
    Youmagic FLM System (YM5-U1)
    Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
    RFMagik Lite
    Electro Lube NXT
    OptaBlate Radiofrequency (RF) Generator System
    FiAPC plus probes
    Sunny
    Vasoview Hemopro 3 Power Supply
    Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
    InbellaBody System
    CROMA Electrosurgical Generator (PRD-EMR-050)
    Venclose digiRF Generator (VCRFG1)
    JETT Medical II
    Reverso Pro System
    Oligio X
    The ETHICON™ Total Energy System
    DUET-V (Model: ESK-3261DV)
    Inbella RF System
    RM STAR EX with RMS Needle
    Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)
    Finiff System
    Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
    Radiofrequency Generator System, Cura RF Electrode
    POTENZA
    Aerin Console
    Cellinew
    Secret MAX Multi-platform RF System
    ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
    Superflow Prime Treatment System (ASP-1M)
    Plasonic (Plasonic)
    POTENZA
    Legend X Desktop System
    PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
    Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
    Vybe RF II
    FiAPC plus probes
    HybridTherm System
    da Vinci E-200 Electrosurgical Generator
    CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)
    Da Vinci Monopolar and Bipolar Adapters (378896)
    InMode RF System

    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