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

    VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES

    K Number: K043594 · Decision Mar 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    33
    Review Days
    92

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    Basic Information

    Device Name
    VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
    K Number
    K043594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    December 29, 2004
    Decision Date
    March 31, 2005
    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 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
    K043225 VANGUARD REPROCESSED ULTRASONIC SCALPEL
    K043315 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    K040751 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    Search all 33 clearances from Vanguard Medical Concepts, Inc. →