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

    PATCHASSIST

    K Number: K101218 · Decision Jun 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    48

    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
    PATCHASSIST
    K Number
    K101218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polytouch Medical, Ltd.
    Date Received
    April 30, 2010
    Decision Date
    June 17, 2010
    Product Code
    ORQ
    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
    ORQ Mesh, Surgical, Deployer

    Similar 510(k) Clearances

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

    BioBrace ® RC Delivery System

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

    ACCUMESH DEPLOYMENT SYSTEM

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

    ACCUMESH DEPLOYMENT SYSTEM

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

    ACCUMESH DEPLOYMENT SYSTEM

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

    PATCHASSIST LARGE

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

    Other Clearances by Polytouch Medical, Ltd.

    K Number Device Name
    K103269 PATCHASSIST LARGE