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

    SURGICAL ADHESIVE TAPE

    K Number: K941943 · Decision Jun 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    1
    Review Days
    70

    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
    SURGICAL ADHESIVE TAPE
    K Number
    K941943
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Raleigh Lions Clinic For the Blind, Inc.
    Date Received
    April 21, 1994
    Decision Date
    June 30, 1994
    Product Code
    KGX
    Advisory Committee
    General Hospital
    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
    KGX Tape And Bandage, Adhesive

    Similar 510(k) Clearances

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

    SERAGARD INJECTION PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARE BAND ANTIBACTERIAL BANDAGES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYVEK PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADHESIVE BANDAGES WITH OTC DRUG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TARGETT PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARALLEL

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all