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

    CUSTOM PROCEDURE TRAY

    K Number: K911565 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    33
    Review Days
    122

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    Basic Information

    Device Name
    CUSTOM PROCEDURE TRAY
    K Number
    K911565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    April 9, 1991
    Decision Date
    August 9, 1991
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Vanguard Medical Concepts, Inc.

    K Number Device Name
    K053051 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
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    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
    K043315 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    Search all 33 clearances from Vanguard Medical Concepts, Inc. →