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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: GZT FDA class 2

    Retractor, Self-Retaining, For Neurosurgery

    Neurology

    View full classification →

    The Self-Retaining Retractor for Neurosurgery is a surgical instrument used during cranial and spinal procedures to hold open the surgical field without continuous manual effort, allowing the surgeon to work with both hands and maintain exposure of operative structures. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZT under regulation 21 CFR 882.4800 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    43 matches
    K Number
    Device Name
    Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
    Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
    MindsEye Expandable Port
    Geister retractor for neuro - and spine surgery
    NICO BrainPath
    MEDICON Spinal Spreading Systems
    Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
    Self-retaining Retractor
    NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
    BRAIN PORT
    SPOTLIGHT ACCESS SYSTEM
    SPOTLIGHT ACCESS SYSTEM
    SCALP DURA RETRACTOR, MODEL KS00474
    SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
    INSTRUMED RETRACTORS
    FLEX ARM RETRACTOR SYSTEM
    PIPELINE II ACCESS SYSTEM
    VYCOR SURGICAL ACCESS SYSTEMS
    GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
    HARMONY PORT SYSTEM, MODEL 1907 SERIES
    THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
    VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
    TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
    HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR
    CERVICAL SELF-RETAINING RETRACTOR
    TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
    CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
    BLADES FOR SPINAL LAMINECTOMY RETRACTOR
    ADSON-BECKMAN RETRACTOR, SPINAL
    NEUROSURGICAL HEADFRAME ACCESSORIES
    ESI MODEL MS-103
    COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
    V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
    MODIFIED MEMORY RETRACTOR ARM
    NEUROSURICAL RETRACTORS - VARIOUS TYPES
    CRANK FRAME RETRACTOR
    CRANK FRAME RETRACTOR
    MEDCO MEMORY RETRACTOR SYSTEM
    SELF-RETAINING RETRACTOR FOR NEUROSURGERY
    CEDAR(TM) RETRACTOR RING
    BUDDE-HALO RETRACTOR
    CYCLOPAC TENS
    DISPOSABLE SKIN RETRACTOR

    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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