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

    DRAPES WITH ABSORBENT REINFORCEMENT

    K Number: K023425 · Decision Nov 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    63
    Review Days
    26

    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
    DRAPES WITH ABSORBENT REINFORCEMENT
    K Number
    K023425
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allegiance Healthcare Corp.
    Date Received
    October 11, 2002
    Decision Date
    November 6, 2002
    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 Allegiance Healthcare Corp.

    K Number Device Name
    K023673 AIRLIFE DEMAND NASAL CANNULA
    K023419 TRILAMINATE DRAPES/TIBURON
    K024120 MODIFICATION TO TEMNO BIOPSY NEEDLES
    K024292 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
    K024102 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K022765 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023170 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023167 BREATHABLE SURGICAL GOWN
    K012931 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
    K020818 POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
    Search all 63 clearances from Allegiance Healthcare Corp. →