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510(k) Data Aggregation

    K Number
    K023372
    Device Name
    NON-BIOABSORBABLE STAPLE
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2002-12-27

    (80 days)

    Product Code
    NJU
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONUX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.
    Device Description
    The subject device is designed to deliver fixation springs via a minimally invasive sterile disposable instrument that is for single patient use. The fixation springs are made of nitinol and are composed of 3 coils that are approximately .18 inches in diameter. The spring is held within the lumen of a needle is inserted through the tissue or prosthetic material to be approximated or fixated and the spring is pushed out so that approximately 1 coil of the spring is released. The needle is then withdrawn from the tissue or prosthetic material while the remainder of the spring is pushed out thereby deploying at least one coil on the proximal surface of the tissue or prosthetic material. Because the spring is manufactured such that the coils are naturally pre-compressed against each other, the distal and proximal coils place a compression force on the tissue or prosthetic material that holds them together.
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    K Number
    K022777
    Device Name
    MANUAL TOUCHE SYSTEM
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2002-11-19

    (90 days)

    Product Code
    GAQ, GAO, HCF
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONUX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).
    Device Description
    A single-use, surgical instrument for placing stainless steel sutures.
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    K Number
    K014286
    Device Name
    SALUTE, MODEL 3022
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2002-03-08

    (71 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONUX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salute Fixation System is indicated for use in a variety of laparoscopic / endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.
    Device Description
    A minor modification has been made to the Salute staples in that a coating has been added to the surface of the staples. A reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs. This instrument may be used laparoscopically with 5mm trocars.
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    K Number
    K010620
    Device Name
    ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2001-05-17

    (77 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONUX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.
    Device Description
    The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.
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    K Number
    K003522
    Device Name
    SALUTE
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2001-02-13

    (90 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONUX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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