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

    PUREGRAFT 50 SYSTEM

    K Number: K132815 · Decision Jan 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    137

    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
    PUREGRAFT 50 SYSTEM
    K Number
    K132815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytori Therapeutics, Inc.
    Date Received
    September 9, 2013
    Decision Date
    January 24, 2014
    Product Code
    MUU
    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
    MUU System, Suction, Lipoplasty

    Similar 510(k) Clearances

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

    IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SyntrFuge System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Smart Kit Basic, Smart Kit Pro

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REVOLVE ENVI 600 Advanced Adipose System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Dermapose Refresh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    JTL-250-01

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Cytori Therapeutics, Inc.

    K Number Device Name
    K113255 PUREGRAFT 850/PURE SYSTEM
    K092923 CYTORI PUREGRAFT 250/PURE SYSTEM
    K072587 CYTORI AFT SYSTEM
    K063235 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
    K060482 CYTORI CELUTION CELL CONCENTRATION DEVICE