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

    JRP Wound Spreader

    K Number: K152538 · Decision Apr 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    222

    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
    JRP Wound Spreader
    K Number
    K152538
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J.R. Parker, LLC
    Date Received
    September 4, 2015
    Decision Date
    April 13, 2016
    Product Code
    GAD
    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
    GAD Retractor

    Similar 510(k) Clearances

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

    OTELO LL

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

    THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES

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

    DASH

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

    APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

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

    QUADRANT RETRACTOR SYSTEM

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

    MRI FASTSYSTEM RETRACTOR SYSTEM

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