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510(k) Data Aggregation

    K Number
    K133857
    Device Name
    BRELLA-SPEC(TM) VAGINAL SPECULUM
    Manufacturer
    PROA MEDICAL, INC.
    Date Cleared
    2014-04-28

    (130 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.
    Device Description
    The Brella-Spec™ Vaginal Speculum is a sterile, single-use device with built-in LED illumination system to provide optimal visualization and access during gynecological and obstetrical procedures. This speculum was designed to provide visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The device is ergonomically designed to maximize the view window using two side blades that are opened by a manually operated ratchet mechanism. The device incorporates a fully enclosed LED illumination system. It is composed of medical grade, biocompatible plastic materials.
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    K Number
    K132668
    Device Name
    IOB DISPOSABLE SPECULUM
    Manufacturer
    IOB MEDICAL INC
    Date Cleared
    2014-01-17

    (143 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.
    Device Description
    The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.
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    K Number
    K130046
    Device Name
    CLEARSPEC SINGLE USE VAGINAL SPECULUM
    Manufacturer
    CLEARSPEC LLC
    Date Cleared
    2013-08-06

    (210 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearSpec Single-Use Vaginal Speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
    Device Description
    The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.
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    K Number
    K120743
    Device Name
    SPECULUM, VAGINAL, NONMETAL
    Manufacturer
    WELCH ALLYN, INC.
    Date Cleared
    2012-03-23

    (11 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KleenSpec® Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal speculum can be used with or without the illuminator. KleenSpec® 790 Series Cordless Illuminator When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source. This product is available for sale only upon the order of a physician or licensed health care professional.
    Device Description
    The subject device has the same technological characteristics and indications for use as the predicate KleenSpec® Single Use Vaginal Speculum. The addition of the extra small size vaginal speculum does not introduce any new concerns regarding safety or efficacy. The designs have been demonstrated as substantial equivalent using bench test data. Both the new size and the previously cleared KleenSpec® Single Use Vaginal Speculums are made of the same materials, which have biocompatibility testing according to FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device and are demonstrated to be suitable for the intended use of this product.
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    K Number
    K110766
    Device Name
    KOLPLUX SYSTEM
    Manufacturer
    KOLPLAST CI LTDA
    Date Cleared
    2011-09-15

    (181 days)

    Product Code
    HIB, DEV
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KOLPLUX System when used with a vaginal speculum provides illumination during pelvic examination and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
    Device Description
    The KOLPLUX System consists of a power source adapter, 2 meter long electrical cord, and the illumination system body and a carrying case. The Illumination System Body accommodates the LED and provides a keyhole female opening for the insertion of the optic fiber tube (found on the vaginal speculum).
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    K Number
    K092870
    Device Name
    NON-STERILE DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    KUNSHAN DEYI PLASTIC CO., LTD.
    Date Cleared
    2010-02-16

    (151 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.
    Device Description
    The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.
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    K Number
    K091937
    Device Name
    OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
    Manufacturer
    OBP CORPORATION
    Date Cleared
    2009-09-09

    (71 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.
    Device Description
    The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.
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    K Number
    K072942
    Device Name
    MEDLINE DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2008-02-08

    (114 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K072762
    Device Name
    DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
    Manufacturer
    DEPALT INC.
    Date Cleared
    2008-01-22

    (116 days)

    Product Code
    HIB, KYT
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations. Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.
    Device Description
    Depalt Vaginal Speculum is a nonmetal, single use (disposable) medical device used to expose the interior of the vagina. The vaginal speculum may be used with or without the Depalt Lighting System. Depalt Lighting System provides the light necessary to illuminate during procedures and examinations.
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    K Number
    K070964
    Device Name
    KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
    Manufacturer
    WELCH ALLYN, INC.
    Date Cleared
    2007-05-18

    (43 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KleenSpec® Single Use Vaginal Speculum: The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal speculum can be used with or without the illuminator. KleenSpec® 790 Series Cordless Illuminator: When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source.
    Device Description
    The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator. When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source.
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