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

    NU-GEL ISLAND WOUND DRESSING

    K Number: K932336 · Decision Feb 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    53
    Review Days
    271

    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
    NU-GEL ISLAND WOUND DRESSING
    K Number
    K932336
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Medical, Inc.
    Date Received
    May 14, 1993
    Decision Date
    February 9, 1994
    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 Johnson & Johnson Medical, Inc.

    K Number Device Name
    K001690 PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
    K982641 ADVANCED NIBP MODULE
    K983362 NU-GEL * WOUND DRESSING
    K982597 FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
    K974080 CRITIKON SOFT BLOOD PRESSURE CUFF
    K980493 I.V. CATHETER SYSTEM
    K972498 OBSERVER * CENTRAL STATION
    K973699 ULTRALON POWDER FREE LATEX SURGICAL GLOVE
    K971569 DINAMAP MPS PORTABLE MONITOR
    K970182 DINAMAP COMPACT MONITOR
    Search all 53 clearances from Johnson & Johnson Medical, Inc. →