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

    Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

    K Number: K153347 · Decision Aug 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    152
    Review Days
    273

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    Basic Information

    Device Name
    Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
    K Number
    K153347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    November 20, 2015
    Decision Date
    August 19, 2016
    Product Code
    GWM
    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
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Codman & Shurtleff, Inc.

    K Number Device Name
    K193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
    K191237 CERENOVUS Large Bore Catheter
    K173192 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
    K172537 Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
    K172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
    K171862 GALAXY G3 Mini Microcoil Delivery System
    K171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
    K171653 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
    K162563 YOGA Microcatheter
    K162437 Codman EDS3 CSF External Drainage System
    Search all 152 clearances from Codman & Shurtleff, Inc. →