BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UNDER BUTTOCKS DRAPE

    K Number: K895404 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    29

    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
    UNDER BUTTOCKS DRAPE
    K Number
    K895404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Plastics, Inc.
    Date Received
    September 7, 1989
    Decision Date
    October 6, 1989
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

    Similar 510(k) Clearances

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

    BeneHold™ Surgical Incise Drape with CHG antimicrobial II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BeneHold Surgical Incise Drape with CHG antimicrobial

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ControlRad Sterile Cover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MediClear PreOp

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Plus Surgical Drapes (EO Sterilized), PMDB-XXX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Medical Plastics, Inc.

    K Number Device Name
    K902384 ABDOMINAL OR C-SECTION DRAPE SHEET
    K896088 FEMORAL ANGIOGRAPHY DRAPE
    K890101 FEMORAL ANGIOGRAPHY DRAPE
    K822072 MPI ELECTROSURGICAL CAPACTIVE DISPER
    K821169 MPI MON-IT II, SMART SAFETY SYSTEM
    K781148 ELECTROSURGICAL PENCIL SYSTEM