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

    REPROCESSED TROCARS

    K Number: K062497 · Decision Jan 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    21
    Review Days
    159

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    Basic Information

    Device Name
    REPROCESSED TROCARS
    K Number
    K062497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascent Healthcare Solutions
    Date Received
    August 25, 2006
    Decision Date
    January 31, 2007
    Product Code
    NLM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NLM Laparoscope, General & Plastic Surgery, Reprocessed

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    Other Clearances by Ascent Healthcare Solutions

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    K100254 REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
    K100537 REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
    K100080 REPROCESSED TROCARS, MODEL B5LT AND CB5LT
    K093702 REPROCESSED ULTRASONIC COAGULATING SHEARS
    K092425 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
    K090323 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
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    Search all 21 clearances from Ascent Healthcare Solutions →