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

    THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE

    K Number: K963675 · Decision Jan 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    8
    Review Days
    136

    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
    THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
    K Number
    K963675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Medical Devices, Inc.
    Date Received
    September 13, 1996
    Decision Date
    January 27, 1997
    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 Micro-Medical Devices, Inc.

    K Number Device Name
    K003695 MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
    K983882 MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
    K951482 ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)
    K951894 ACCESS EXPANSION SYSTEM
    K945656 THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
    K940141 LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
    K936213 ARTHROSCOPES AND ACCESSORIES