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: GEY FDA class 1

    Motor, Surgical Instrument, Ac-Powered

    General, Plastic Surgery

    View full classification →

    The Motor, Surgical Instrument, AC-Powered (product code GEY) is an electrically powered drive unit used to operate surgical instrument attachments such as drills, saws, and burrs during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device carries no special flags for implantation, life support, GMP exemption, or third-party review.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    ADVANCED TURBO DRIVE SYSTEM
    ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
    SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
    MEDNEXT 1000 DRILL
    AQUA SPRAY
    BONE AND MARROW COLLECTION SYSTEM KIT
    BONE & MARROW CLLECTION SYSTEM
    ORTHOCHUCK
    ANSPACH LUBRICATING SYSTEM II
    BME BONE DRILL BITS
    SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
    BONE & MARROW COLLECTION SYSTEM
    SURGIMOTOR
    PODOSPRAY DRILL SYSTEM
    KARL STORZ DRILL
    3M MAXI-DRIVER II ELECTRIC SYSTEM
    AUTO LUBE SYSTEM
    ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS
    CUTO(TM) TISSUE MORCELLATION SYSTEM
    ES-100 POWER SYSTEM, ES-100 SERIES
    AESCULAP SURGICAL ACCESSORIES
    MICRO-AIRE MODEL 2060
    MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS
    2710-000 OSCILLATING SAW, GENERAL ASSEMBLY
    VISTEK ELECTRONIC CONTROLLER
    MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
    PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.
    MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS
    MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS
    THE DEXTRA PRECISION POWER UNIT
    ISOMETRIC ACL DRILL GUIDE
    DRILLING TEMPLATE
    MULTIPLE OUTLET MANIFOLD
    MINUTEMAN CO2 MICROSURG LASER GEN SURG
    MINUTEMAN C02 MICROSURG LASER PODIATRY
    MINUTEMAN CO2 MICROSURG LASER DERMATOL-
    RICHARDS INTRA-ARTICULAR SHAVER MOTOR
    ELECTRO SURGERY SYSTEM
    RICHARDS INTRA-ARTICULAR SHAVER BLADES
    SAGITTAL SAW
    150 DRIVER REAMER

    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