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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: ERL FDA class 2

    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    Ear, Nose, Throat

    View full classification →

    The ENT surgical drill (electric or pneumatic, including handpiece) is a powered instrument used for precision bone removal and shaping in ENT surgical procedures such as mastoidectomy, cochlear implantation surgery, and sinus procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is ERL, regulated under 21 CFR 874.4250 in the Ear, Nose, Throat specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
    hekaDrill
    ORiGO System
    AMADEO, M-UK1015 (incl. attachments and accessories)
    Celeris, Disposable Sinus Debrider
    Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
    UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
    EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
    OCM-G1 Attachment
    Stryker Consolidated Operating Room Equipment (CORE) 2 Console
    3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
    DragonFly Surgical Drill System
    PolypVac Microdebrider (3.3mm and 4.0mm)
    DIEGO ELITE DRILL
    Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
    Pi Drive Plus Motor, Extender
    XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
    OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
    STRYKER S2 DRILL
    ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
    LAURIMED POLYPVAC MICRODEBRIDER
    DTAD
    STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
    OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
    REPROCESSED ENT SHAVERS
    STRYKER ESSX WITH NAVIGATION MOUNT
    PRIMADO SURGICAL DRILL
    XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
    STRYKER ESSX MICRODEBRIDER SYSTEM
    XPS 3000 SYSTEM
    KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
    XPS 3000 SYSTEM
    XPS 3000 SYSTEM
    DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
    STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
    SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    DAUM-LECTRIC MRI DRILLING MACHINE
    UNIDRIVE II PLUS DISPOSABLE TUBING SET
    DIEGO POWERED DISSECTOR AND DRILL SYSTEM
    SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
    MODIFICATION TO XPS 3000 SYSTEM
    HUMMER IV MICRODEBRIDER SYSTEM
    KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
    XPS 3000 SYSTEM
    XPS NITRO SYSTEM
    TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
    HUMMER TRAK SYSTEM
    PNEUMATIC CUTTER SYSTEM
    XPS DRILL SYSTEM
    SLT BIPOLAR SHEATH

    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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