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510(k) Data Aggregation

    K Number
    K021224
    Device Name
    ENDOCERVICAL BLOCK NEEDLE
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    2002-07-12

    (86 days)

    Product Code
    HEE, FMI
    Regulation Number
    884.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.
    Device Description
    The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.
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    K Number
    K020711
    Device Name
    WALLACH LOOP ELECTRODE
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    2002-06-03

    (90 days)

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

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.
    Device Description
    The Wallach LOOP Electrode is a Sterile, Disposable, Single Use Electrode. Used in conjunction with an ESU (electrosurtical unit or generator) to CUT or COAG during an electorsurgical procedure.
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    K Number
    K000768
    Device Name
    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    2000-04-11

    (33 days)

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

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992736
    Device Name
    WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1999-09-29

    (47 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures and is inserted into the vagina to expose the cervix. It is supplied non-sterile and is intended to be autoclavable for 100+ cycles.
    Device Description
    The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the vagina during general gynecologic and electrosurgical procedures. The non-conductive, specialized plastic stops dangerous grounding of the electrical current that a metal would not. The stainless steel metal parts will not rust and are away from the operating area. The three main parts are injection molded from a plastic called ULTEM, a General Electric Company product used for many years in the manufacturing of medical devices, where high temperature and chemical interaction is a concern. The speculum has been autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles and there is no coating to breakdown, crack, chip, or peel. The color is pink to stop light reflection (as opposed to white) and still light enough to show any surface damage that might happen in use. The surfaces are polished and all sharp edges are removed for the protection of the patient.
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    K Number
    K991669
    Device Name
    PMS 750 FINGERSWITCH
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1999-08-12

    (90 days)

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

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PMS750 Fingerswitch is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided non-sterile and is intended for limited reuse. The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.
    Device Description
    The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcontrol pencil. It utilizes an insert-molded body that houses a printed circuit board; depression of the yellow button will activate the CUT circuit and depression of the blue button will activate the COAG circuit. It is an accessory to an ESU (electrosurgical unit or generator).
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    K Number
    K983840
    Device Name
    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1999-05-20

    (202 days)

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

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include: 1) Cervical Conization. 2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias. 3) External Anogenital Lesions. 4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions. 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.
    Device Description
    Not Found
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    K Number
    K984306
    Device Name
    `THE INSEMINATOR' (PROPOSED)
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1999-03-01

    (89 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.
    Device Description
    The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.
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    K Number
    K983208
    Device Name
    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1999-02-22

    (161 days)

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

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include: - 1) Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection. - 2) Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures. - 3) Hemostasis control of bleeding, epilation, and telangiectasia. - 4) Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis. - 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.
    Device Description
    Not Found
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    K Number
    K963653
    Device Name
    WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1997-06-11

    (272 days)

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

    WALLACH SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Quantum 2000 System is for in-office electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include: 1) Cervical Conization. 2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias. 3) External Anogenital Lesions. 4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
    Device Description
    WALLACH QUNATUM 2000 ELECTROSURGICAL SYSTEM
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    K Number
    K963348
    Device Name
    WALLACH INTEGRATION UNIT
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Date Cleared
    1997-03-19

    (205 days)

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

    WALLACH SURGICAL DEVICES, INC.

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

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