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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: KNF FDA class 2

    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

    Obstetrics/Gynecology

    View full classification →

    An Endoscopic Unipolar Coagulator-Cutter with Accessories is an electrosurgical device used in gynecologic laparoscopy to cut and coagulate tissue using high-frequency electrical current through a single active electrode, applied in procedures such as tubal ligation and laparoscopic surgery. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNF and it is regulated under 21 CFR 884.4160 in the Obstetrics and Gynecology specialty. This device is eligible for third-party review.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    Sonata Transcervical Fibroid Ablation System 2.2
    Sonata Transcervical Fibroid Ablation System 2.2
    Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
    Sonata Transcervical Fibroid Ablation System 2.2
    Sonata Transcervical Fibroid Ablation System 2.2
    Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
    Sonata Sonography-Guided Transcervical Fibroid Ablation System
    LINA GOLD LOOP HC
    MODULAP LOOP
    JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
    LAP LOOP
    LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
    LAPARETTE, MODEL LAP J L S H N
    AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
    ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
    EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
    OMNITECH RESECTOSCOPE ROLLER ELECTRODE
    OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
    VAPORIZATION ELECTRODES
    ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
    MICRO ELECTRODES
    LAPARETTE
    VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
    RESISTICK SOLID LAPAROSCOPIC ELECTRODES
    FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
    SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES
    NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
    NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
    KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
    KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
    MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES
    KARL STORZ INSULATED BIOPSY FORCEPS
    KARL STORZ INSULATED SCISSORS
    GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.
    CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575
    JARIT SURGICAL INSTRUMENTS
    ENDOMED LAPAROSCOPY INSTRUMENTS
    HI-TOPS ELECTRODES 14-8000
    REFLEX(R) ESC
    GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES
    ELECTRO-GYNE ELECTROSURGICAL GENERATOR
    SCISSORS, HOOK, ELECTROSURGICAL
    SCISSORS, HOOK, ELECTROSURGICAL
    PROBE, COAGULATION ACCESSORY

    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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