BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019

    K Number: K061135 · Decision Jul 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    10
    Review Days
    78

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
    K Number
    K061135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap
    Date Received
    April 24, 2006
    Decision Date
    July 11, 2006
    Product Code
    GWG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWG Endoscope, Neurological

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GWG), ordered by most recent decision date.

    Precision S 4K Sinuscope

    FDA 510(k)
    FDA Class 2 ·Neurology

    Hydro Irrigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    HJY VisualNext 3D Endoscopic Vision System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

    FDA 510(k)
    FDA Class 2 ·Neurology

    cCeLL - In vivo

    FDA 510(k)
    FDA Class 2 ·Neurology

    Digital ClarusScope System, Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Aesculap

    K Number Device Name
    K093649 AESCULAP STERILCONTAINER S
    K062085 S4 SPINAL SYSTEM
    K062510 AESCULAP STERILCONTAINER SYSTEM
    K043079 BICONTACT HIP SYSTEM WITH U-CAP
    K040865 AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
    K040191 BICONTACT HIP STEM AND FEMORAL HEAD
    K040864 CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
    K031216 MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
    K031008 AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)