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510(k) Data Aggregation

    K Number
    K993046
    Device Name
    FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1999-11-22

    (73 days)

    Product Code
    FEO
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBRA SONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fibra Sonics LithoSonic Model LS-2000 Ultrasonic Lithotripsy System is intended to fragment urinary calculi in the kidney, ureter, and bladder.
    Device Description
    Not Found
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    K Number
    K984199
    Device Name
    EXONIX
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1999-02-17

    (85 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBRA SONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fibra Sonics Exonix Ultrasound device is used to produce therapeutic deep heat for the following conditions: - Temporary relief of pain - Muscle Spasms - Joint contractures
    Device Description
    Not Found
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    K Number
    K984143
    Device Name
    FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1999-02-16

    (90 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBRA SONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitreoretinal Procedures (Ultrasonic emulsification and removal of cataracts)
    Device Description
    Fibra-Sonics Phaco III and IIIP Fragmentation System
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    K Number
    K983199
    Device Name
    FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1998-12-14

    (91 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBRA SONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed or use in the The Flora Somes Offication and aspiration of soft tissues as used in the following surgical areas: NEUROSURGERY For the ablation and aspiration of various intracranial and spinal cord soft tissue tumors, which may include but are not necessarily limited to the following: Astrocytoma Pituitary adeonoma Acoustic neuroma Meningioma Glioma Brain stem tumors Spinal cord tumors. GASTROENTEROLOGY Various Gastroenterological and General surgery procedures along the GI tract , which may include, but are not necessarily limited to the following: Hepatic resection Liver trauma Hepatic cysts Colon cancer Rectal Tumor Bowel tumor Retropertioneal turnor ORTHOPEDICS Various orthopedic procedures which may include, but are not necessarily limited to the following: Discectomy
    Device Description
    Fibra Sonics Ultrasonic Surgical Aspirator Model 1000
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    K Number
    K980930
    Device Name
    FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1998-09-22

    (194 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBRA SONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues as used in the following surgical areas: - (a) Neurosurgery - (b) Gastrointestinal and affiliated organ surgery - (c) Urological surgery - (d) Plastic and reconstructive surgery - (e) Gynecological procedures - (f) Orthopedic Surgery These indicated uses are equivalent to the predicate device. Appropriate warnings and cautions are indicated in the Operator's Manual.
    Device Description
    Not Found
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