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

    DEROYAL HYDROGEL DRESSING

    K Number: K915182 · Decision Apr 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    91
    Review Days
    158

    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
    DEROYAL HYDROGEL DRESSING
    K Number
    K915182
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Deroyal Industries, Inc.
    Date Received
    November 15, 1991
    Decision Date
    April 21, 1992
    Product Code
    NAE
    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
    NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic

    Similar 510(k) Clearances

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

    MODIFICATION TO ZENIEVA

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

    MODIFICATION TO ZENIEVA

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

    ZENIEVA

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

    GILTECH PLUS HYDROGEL SKIN DRESSING

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

    DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

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

    AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES

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