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

    REPROCESSED ULTRASONIC SCALPELS

    K Number: K043358 · Decision Jun 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    36
    Review Days
    182

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    Basic Information

    Device Name
    REPROCESSED ULTRASONIC SCALPELS
    K Number
    K043358
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Medical Corp.
    Date Received
    December 6, 2004
    Decision Date
    June 6, 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 Alliance Medical Corp.

    K Number Device Name
    K060648 REPROCESSED PHACOEMULSIFICATION TIPS
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    K060049 REPROCESSED COMPRESSION SLEEVES
    K060091 ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
    K053316 REPROCESSED COMPRESSION SLEEVES
    K052918 REPROCESSED EXTERNAL FIXATION DEVICES
    K052603 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
    K052414 REPROCESSED ELECTROPHYSIOLOGY CATHETER
    K052064 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
    K052062 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
    Search all 36 clearances from Alliance Medical Corp. →