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

    QUALTEX ISLAND DRESSING

    K Number: K910657 · Decision Jul 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    91
    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
    QUALTEX ISLAND DRESSING
    K Number
    K910657
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Deroyal Industries, Inc.
    Date Received
    February 14, 1991
    Decision Date
    July 1, 1991
    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

    Other Clearances by Deroyal Industries, Inc.

    K Number Device Name
    K250586 Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
    K230233 Prospera Spectruum Negative Pressure Wound Therapy System
    K200631 DeRoyal Temperature Monitoring Probe
    K200757 Foley Catheter with Temperature Sensor
    K200319 HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
    K193027 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
    K191425 Hydro-Temp Neonatal Skin Temperature Probe Cover
    K173072 Algidex Ag Silver Alginate Wound Dressing
    K171475 DeRoyal Laprador Specimen Retrieval System
    K152978 DeRoyal Angiography Kits
    Search all 91 clearances from Deroyal Industries, Inc. →