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

    CODMAN INTRACRANIAL BOLT

    K Number: K974088 · Decision Jan 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    206
    Review Days
    71

    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
    CODMAN INTRACRANIAL BOLT
    K Number
    K974088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    October 30, 1997
    Decision Date
    January 9, 1998
    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

    Similar 510(k) Clearances

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

    Pressio 3 Multi-parameter Neuromonitoring System

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

    FDA 510(k)
    FDA Class 2 ·Neurology

    B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

    FDA 510(k)
    FDA Class 2 ·Neurology

    B4C System

    FDA 510(k)
    FDA Class 2 ·Neurology

    CereLink ICP Monitor

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

    Other Clearances by Johnson & Johnson Professionals, Inc.

    K Number Device Name
    K992173 SIPHONGUARD CSF CONTROL DEVICE
    K991413 CODMAN ETHISORB DURA PATCH
    K991222 CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
    K982379 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
    K982812 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
    K983141 CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
    K983014 SUMMIT ACETABULAR SYSTEM
    K980778 HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
    K974739 HAKIM PROGRAMMABLE VALVE SYSTEM
    K980801 J-FX BIPOLAR HEAD
    Search all 206 clearances from Johnson & Johnson Professionals, Inc. →