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510(k) Data Aggregation

    K Number
    K241748
    Device Name
    Intimate Rose Vaginal Dilators
    Manufacturer
    Plus EV Holdings dba Intimate Rose
    Date Cleared
    2024-08-14

    (57 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intimate Rose Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
    Device Description
    The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to <= 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.
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    K Number
    K233689
    Device Name
    Hope&Her Vaginal Dilators
    Manufacturer
    Lujena, Inc.
    Date Cleared
    2024-05-02

    (167 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hope&Her Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
    Device Description
    Not Found
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    K Number
    K222492
    Device Name
    Hope&Her Vaginal Dilators
    Manufacturer
    Lujena, Inc.
    Date Cleared
    2023-06-27

    (314 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.
    Device Description
    Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.
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    K Number
    K231430
    Device Name
    Intimate Rose Vaginal Dilators
    Manufacturer
    Plus EV Holdings dba Intimate Rose
    Date Cleared
    2023-06-07

    (21 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.
    Device Description
    The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to ≤ 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.
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    K Number
    K220035
    Device Name
    Milli Vaginal Dilator
    Manufacturer
    Materna Medical
    Date Cleared
    2023-02-27

    (418 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
    Device Description
    The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy for vaginal tightness through stretching of the vaginal tissue under electromechanical expansion, one millimeter at a time. The Milli Vaginal Dilator expands electronically in increments of 1mm from a baseline of 15mm to 40mm in diameter. Dilation and contraction of the Milli Vaginal Dilator is at the control of the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted, eliminating the need for removal and insertion of larger sizes. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired to promote relaxation. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The subject device is intended to be sold over the counter (OTC), to be purchased online without the support of a healthcare provider.
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    K Number
    K211959
    Device Name
    Milli Vaginal Dilator
    Manufacturer
    Materna Medical
    Date Cleared
    2021-12-01

    (160 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia.
    Device Description
    The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion. The device is intended for use for adult women (>=18 years) who need controlled vaginal dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia. The Milli Vaginal Dilator expands electronically in increments of 1mm from a baseline of 15mm to 40mm in diameter. Dilation and contraction of the Milli Vaginal Dilator are completed by the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The Milli Vaginal Dilator is intended for use in a home or healthcare environment. The device is intended for prescription (Rx) use, and the treatment duration, frequency, and length are specified in the Instructions for Use and/or at the discretion of the physician.
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    K Number
    K202542
    Device Name
    Allura Vaginal Stent
    Manufacturer
    PMT Corporation
    Date Cleared
    2020-09-30

    (28 days)

    Product Code
    KXP
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.
    Device Description
    Not Found
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    K Number
    K130273
    Device Name
    PANPAC VAGINAL DILATORS
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2013-08-08

    (185 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.
    Device Description
    Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.
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    K Number
    K071754
    Device Name
    NEO-VAGINA SURGERY SET AND ACCESSORIES
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2009-01-07

    (559 days)

    Product Code
    HDX
    Regulation Number
    884.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery.
    Device Description
    The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons to be placed in the vagina to enlarge the vaginal cavity and maintain the vaginal canal after laparoscopic-assisted creation of a neo-vagina.
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    K Number
    K063562
    Device Name
    GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2007-02-26

    (91 days)

    Product Code
    OTP
    Regulation Number
    884.5980
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.
    Device Description
    The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support.
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