BEUDAMED
    Product Code: GZT FDA class 2 21 CFR 882.4800

    Retractor, Self-Retaining, For Neurosurgery

    Neurology

    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.

    View on FDA
    510(k)s
    43
    FEI Numbers
    84
    Registration Numbers
    84
    Unique Applicants
    38
    Years Active
    42

    Basic Information

    Product Code
    GZT
    Device Class
    FDA class 2
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 43 510(k) clearances via K numbers.

    K Number Device Name
    K210615 Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
    K202694 Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
    K202072 MindsEye Expandable Port
    K180610 Geister retractor for neuro - and spine surgery
    K172433 NICO BrainPath
    K161680 MEDICON Spinal Spreading Systems
    K161318 Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
    K161004 Self-retaining Retractor
    K150378 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
    K120691 BRAIN PORT
    K113273 SPOTLIGHT ACCESS SYSTEM
    K112913 SPOTLIGHT ACCESS SYSTEM
    K093054 SCALP DURA RETRACTOR, MODEL KS00474
    K090272 SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
    K071771 INSTRUMED RETRACTORS
    K071338 FLEX ARM RETRACTOR SYSTEM
    K062814 PIPELINE II ACCESS SYSTEM
    K060973 VYCOR SURGICAL ACCESS SYSTEMS
    K060097 GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
    K050706 HARMONY PORT SYSTEM, MODEL 1907 SERIES
    K992898 THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
    K964402 VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
    K960807 TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
    K945040 HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR
    K935529 CERVICAL SELF-RETAINING RETRACTOR
    K924876 TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
    K913233 CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
    K910621 BLADES FOR SPINAL LAMINECTOMY RETRACTOR
    K905445 ADSON-BECKMAN RETRACTOR, SPINAL
    K902517 NEUROSURGICAL HEADFRAME ACCESSORIES
    K885120 ESI MODEL MS-103
    K896156 COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
    K895395 V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
    K895537 MODIFIED MEMORY RETRACTOR ARM
    K892543 NEUROSURICAL RETRACTORS - VARIOUS TYPES
    K882071 CRANK FRAME RETRACTOR
    K881160 CRANK FRAME RETRACTOR
    K874829 MEDCO MEMORY RETRACTOR SYSTEM
    K874956 SELF-RETAINING RETRACTOR FOR NEUROSURGERY
    K873691 CEDAR(TM) RETRACTOR RING
    K830332 BUDDE-HALO RETRACTOR
    K801855 CYCLOPAC TENS
    K801151 DISPOSABLE SKIN RETRACTOR

    FEI Numbers

    This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.