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510(k) Data Aggregation

    K Number
    K050364
    Device Name
    MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    2005-03-09

    (23 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MALIS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.
    Device Description
    The Malis 2000 Bipolar Electrosurgical System includes the generator, a Bipedal footswitch for operating the cutting and coagulation functions, a connecting cable to allow the use of a MALIS irrigator with the MALIS 2000 generator. The unit incorporates the use of a LCD panel to make it easier for the surgeon to see the setting.
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    K Number
    K042604
    Device Name
    VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    2004-10-22

    (28 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand Officening vising high frequency (RF) current.
    Device Description
    Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.
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    K Number
    K032601
    Device Name
    STRYKER INTERVENTIONAL PAIN RF GENERATOR
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    2004-04-01

    (220 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthopedic, arthroscopic, 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.
    Device Description
    The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthroscopic, spinal, and neurosurgical applications.
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    K Number
    K033499
    Device Name
    MALIS IRRIGATION MODULE 1000
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    2003-11-28

    (23 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.
    Device Description
    The MALIS™ Irrigation Module 1000 is an irrigation control system for use with the MALIS™ CMC-III Bipolar Electrosurgical Systems and the Synergy MALIS™ Precision System. This system provides controlled flow of irrigating fluid across the tips of bipolar irrigating forceps.
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    K Number
    K982229
    Device Name
    BI-DENT
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1998-08-13

    (90 days)

    Product Code
    EKZ
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Valley Forge Bi-Dent Electrosurgical System is intended for the Dental Practitioner for the cutting and coagulation of oral tissue.
    Device Description
    The Valley Forge Bi-Dent Electrosurgical System is a Bipolar Surgical System. It is a Bipolar Coagulator/Cutting System with integrated irrigation. It incorporates the effectiveness and safety features of bipolar coagulation/cutting and irrigation packaged into one functional unit. Some of the effective safety features of the Bipolar Coagulator/Cutting System are: Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns. Bipolar Cutting/Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current. Bipolar Technology works at voltages approximately 1/10th the voltage required for monopolar technique. Localized Bipolar Cutting/Coagulation gives the surgeon precise control of the electric current at the tissue site. The System's patented waveform and exceedingly low Output Impedance provide superior Cutting/Coagulation and the absence of charring and sticking even in a dry field. Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field. The Bipolar Coagulator/Cutting System offers an Irrigation Delivery System to keep tissue moist and cool during coagulation. Because of the System's ability to work in a wet field, tissue samples removed for biopsy are not charred or desiccated. Unlike monopolar systems, the Bipolar Coagulator/Cutting System provides smooth, progressive coagulation with precise flow-controlled irrigation. The System permits the physician to cut and coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues. The waveform parameters of the Bipolar Coagulator/Cutting System are programed for the smoothest, most gentle, precise and efficient coagulation and cutting of tissue during any surgical procedure.
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    K Number
    K973554
    Device Name
    VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1997-12-19

    (91 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bipolar ball electrodes are designed for electrosurgical coagulation of soft tissue in a bloody, irrigated or wet surgical field.
    Device Description
    Bipolar Ball Electrodes
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    K Number
    K971986
    Device Name
    VALLEY FORGE BIPOLAR LOOP
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1997-08-26

    (89 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Valley Forge bipolar loop electrodes are designed for electrosurgical excisions in a dry, infiltrated or wet field. Gynecological indications are as follows: * loop excisions of the cervix * cervical conizations * external anogenital lesions * large vaginal intraepithelial neoplastic lesions
    Device Description
    Valley Forge Scientific Corp, the manufacturer of several Malis bipolar coagulation/cutting systems, now plans to introduce Bipolar Loop Electrodes for gynecological procedures.
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    K Number
    K964143
    Device Name
    MINI-SYMM BIPOLAR COAGULATOR
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1997-01-09

    (84 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Valley Forge Scientific Corp., the manufacturer of several electrosurgical systems, now plans to introduce a new MINI-SYMM Bipolar System which enables the surgeon to coagulate while irrigating the surgical field.
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    K Number
    K955764
    Device Name
    VALLEY FORGE BIPLOAR LOOP
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1996-03-01

    (72 days)

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

    VALLEY FORGE SCIENTIFIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Valley Forge Scientific Corp., the manufacturer of several Malis solid state bipolar coagulation/cutting systems, now plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.
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