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510(k) Data Aggregation

    K Number
    K160103
    Device Name
    Spetzler Malis Dual Illuminating Bipolar Forceps
    Manufacturer
    SYNERGETICS
    Date Cleared
    2016-10-12

    (267 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.
    Device Description
    The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.
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    K Number
    K143123
    Device Name
    Synergetics PHOTON EX
    Manufacturer
    Synergetics
    Date Cleared
    2015-02-24

    (116 days)

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

    Synergetics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.
    Device Description
    The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.
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    K Number
    K121426
    Device Name
    AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
    Manufacturer
    SYNERGETICS, INC
    Date Cleared
    2012-07-10

    (57 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
    Device Description
    The Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps are sterile single use devices for use in electrosurgery. The forceps are a bayonet style and include a cord at the proximal end which allows for connection to a Malis bipolar electrosurgical generator.
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    K Number
    K121675
    Device Name
    VERSAVIT
    Manufacturer
    SYNERGETICS, INC
    Date Cleared
    2012-06-21

    (15 days)

    Product Code
    HQE, HOE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.
    Device Description
    The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source.
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    K Number
    K113857
    Device Name
    SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
    Manufacturer
    SYNERGETICS, INC
    Date Cleared
    2012-04-23

    (115 days)

    Product Code
    HQB
    Regulation Number
    886.4690
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synergetics Disposable Directional Endo Ocular Laser Probe provides a mean for delivering endophotocoagulation during vitrectomy surgery.
    Device Description
    The Synergetics™ Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthalmic laser delivery device. The Laser Probe assembly includes a probe tip (distal end), a handpiece and a coupling means (proximal end) for connecting the Laser Probe to a commercially available laser source. Glass optic fiber protected by PVC tubing is provided between the handpiece and the coupling means. The probe tip, handpiece, tubing and coupling include a passageway for an optic fiber to transmit laser energy from the proximal end through the assembly to the distal end of the probe tip includes a rounded circumferential edge and smooth distal end surface to minimize tearing or snagging of tissue during insertion of the probe assembly through an incision at the sclera at pars plana. The laser fibers work on the principle of total reflection. Laser energy is focused into the glass silica fiber at the proximal end of the probe and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser through the proximal end through the assembly to the distal end of the laser probe.
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    K Number
    K110924
    Device Name
    DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
    Manufacturer
    SYNERGETICS, INC
    Date Cleared
    2011-12-07

    (247 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
    Device Description
    The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consists of dual inlet irrigating pathways that run along side of the forceps from the proximal end the distal end. This allows the surgeon to view the surgical field without obstruction allowing the fluid to irrigate through the irrigation module through the forceps.
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    K Number
    K091441
    Device Name
    SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
    Manufacturer
    SYNERGETICS, INC.
    Date Cleared
    2009-10-30

    (168 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.
    Device Description
    The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The tubing set consists of a three channel IV spike, for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to deliver air from an air supply unit through the solution; while the dual PVC tubing also administers humidified air (clear lumen) and saline (green stripe lumen); this dual PVC tubing has a three-way stopcock for proper connection.
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    K Number
    K071482
    Device Name
    STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
    Manufacturer
    SYNERGETICS, INC
    Date Cleared
    2007-12-20

    (204 days)

    Product Code
    GXD, GEI
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker RF Multi-Lesion Generator, in combination with the Stryker RF Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. The Stryker RF Multi-Lesion Generator in combination with a Smith & Nephew SPINECATH™ & Acutherm™ catheters are intended for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
    Device Description
    The Stryker RF Multi Lesion Generator will be used in conjunction with Stryker RF Electrodes and Cannula for ablation and coagulation of soft tissue. The generator applies temperature controlled radio frequency RF energy into targeted tissue via an electrode probe, resulting in cellular necrosis. In the case of interventional pain applications, pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue. In addition, the Stryker RF Multi-Lesion Generator allows multiple areas to be targeted and treated concurrently. By treating multiple areas concurrently, overall procedure time can be reduced while maintaining thermal treatments each equivalent to an individual treatment The Stryker RF Multi-lesion System is a bipolar and monopolar, high frequency electrosurgical system. The System consists of the following components: a RF generator, footswitch hand controller, monopolar and bipolar electrodes, cannulae, neutral electrodes, coaxial bipolar electrodes and cannula, parallel bipolar adapter, connecting cables, and intradiscal cable,
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    K Number
    K063489
    Device Name
    STRYKER INTRADISCAL RF GENERATOR
    Manufacturer
    SYNERGETICS, INC.
    Date Cleared
    2007-05-23

    (187 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.
    Device Description
    The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
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    K Number
    K032598
    Device Name
    SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
    Manufacturer
    SYNERGETICS, INC.
    Date Cleared
    2003-11-24

    (91 days)

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

    SYNERGETICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
    Device Description
    The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
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