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

    BANDAGE ROLL, GAUZE

    K Number: K913779 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    5
    Review Days
    112

    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
    BANDAGE ROLL, GAUZE
    K Number
    K913779
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Keilei Intl., Inc.
    Date Received
    August 14, 1991
    Decision Date
    December 4, 1991
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

    Similar 510(k) Clearances

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

    IVALON EXTERNAL SPONGE

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

    ISOLYER (4X4, 8PLY)

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

    OMNISORB II, NONWOVEN SPONGE, STERILE AND NON

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

    MULTI-TRAUMA DRESSING

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

    K-BAND AND K-CREPE

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

    STERILE GAUZE PADS

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

    Other Clearances by Keilei Intl., Inc.

    K Number Device Name
    K912779 GAUZE SPONGE,STERILE 2'S
    K913575 GAUZE PACKING, SURGICAL STERILE AND NON-STERILE
    K895372 X-RAY DETECTABLE GAUZE SPONGE
    K895086 GAUZE SPONGE