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

    ORION STERILE OR TOWELS

    K Number: K903117 · Decision Dec 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    33
    Review Days
    168

    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
    ORION STERILE OR TOWELS
    K Number
    K903117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Orion Life Systems, Inc.
    Date Received
    July 16, 1990
    Decision Date
    December 31, 1990
    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 Orion Life Systems, Inc.

    K Number Device Name
    K943835 PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
    K943834 STERILE .9% SODIUM CHLORIDE SOLUTION
    K943830 PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
    K943836 PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
    K943831 PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
    K943832 STERILE .9% SODIUM CHLORIDE FOR IRRATION
    K943829 PRE-FILLED SYSRINGE W/STERILE WATER
    K943828 STERILE WATER FOR IRRIGATION
    K943833 STERILE WATER FOR IRRATION
    K923168 DUAL PORT ENTERAL Y-ADAPTOR
    Search all 33 clearances from Orion Life Systems, Inc. →