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

    ADULT INCONTINET BRIEF

    K Number: K821397 · Decision May 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    417
    Registration Numbers
    418
    Same Product Code
    55
    Applicant Total
    206
    Review Days
    13

    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
    ADULT INCONTINET BRIEF
    K Number
    K821397
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5920
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    May 11, 1982
    Decision Date
    May 24, 1982
    Product Code
    EYQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EYQ Garment, Protective, For Incontinence

    Similar 510(k) Clearances

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

    DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    KIT PAK INCONTINENT SKIN CARE KIT

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    DEODORIZING AND SOUND MUFFLING ANAL PAD

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    LIB SYSTEM, BABY/ADULT DIAPER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    INTERA SHIELD AND INTERA UNDERGARMENT

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    DRIPRIDE PROVIDE SLIM

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology
    View all

    Other Clearances by Johnson & Johnson Professionals, Inc.

    K Number Device Name
    K992173 SIPHONGUARD CSF CONTROL DEVICE
    K991413 CODMAN ETHISORB DURA PATCH
    K991222 CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
    K982379 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
    K982812 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
    K983141 CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
    K983014 SUMMIT ACETABULAR SYSTEM
    K980778 HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
    K974739 HAKIM PROGRAMMABLE VALVE SYSTEM
    K980801 J-FX BIPOLAR HEAD
    Search all 206 clearances from Johnson & Johnson Professionals, Inc. →