BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AART SILICONE TUBING

    K Number: K022306 · Decision Oct 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    214
    Registration Numbers
    214
    Same Product Code
    28
    Applicant Total
    10
    Review Days
    86

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AART SILICONE TUBING
    K Number
    K022306
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesthetic and Reconstructive Technologies, Inc.
    Date Received
    July 16, 2002
    Decision Date
    October 10, 2002
    Product Code
    KGZ
    Advisory Committee
    General, Plastic Surgery
    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
    KGZ Accessories, Catheter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KGZ), ordered by most recent decision date.

    BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    WOUND DRAINAGE HOLDER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DURALASTIC SILICONE TUBING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NAVARRE PERCUTANEOUS ACCESS SET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PALESTRANT IRRIGATION AND DRAINAGE SET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OPTICAL CATHETER(TM) INTRODUCER SETS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Aesthetic and Reconstructive Technologies, Inc.

    K Number Device Name
    K023678 DIMISIL SCAR GEL
    K022511 AART CALF IMPLANT
    K022223 AART SILICONE SHEETING
    K021820 AART SILICONE CARVING BLOCK
    K021839 AART GLUTEAL IMPLANT
    K021337 AART PECTORALIS IMPLANT
    K021417 AART CHIN IMPLANT
    K021419 AART MALAR IMPLANT
    K021418 AART NASAL IMPLANT