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

    VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL

    K Number: K043315 · Decision Mar 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    33
    Review Days
    111

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    Basic Information

    Device Name
    VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    K Number
    K043315
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    December 1, 2004
    Decision Date
    March 22, 2005
    Product Code
    NLQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments

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    Other Clearances by Vanguard Medical Concepts, Inc.

    K Number Device Name
    K053051 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051616 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051180 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051043 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K050763 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K043198 VANGUARD REPROCESSED ARTHROSCOPIC WANDS
    K043253 VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
    K043594 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
    K043225 VANGUARD REPROCESSED ULTRASONIC SCALPEL
    K040751 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    Search all 33 clearances from Vanguard Medical Concepts, Inc. →