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Found 12 results
510(k) Data Aggregation
K Number
K241748Device Name
Intimate Rose Vaginal Dilators
Manufacturer
Plus EV Holdings dba Intimate Rose
Date Cleared
2024-08-14
(57 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
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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
K233689Device Name
Hope&Her Vaginal Dilators
Manufacturer
Lujena, Inc.
Date Cleared
2024-05-02
(167 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
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Matched: '884.3900'
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
K222492Device Name
Hope&Her Vaginal Dilators
Manufacturer
Lujena, Inc.
Date Cleared
2023-06-27
(314 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
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Matched: '884.3900'
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
K231430Device Name
Intimate Rose Vaginal Dilators
Manufacturer
Plus EV Holdings dba Intimate Rose
Date Cleared
2023-06-07
(21 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
Search-Everything :
Matched: '884.3900'
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
K220035Device Name
Milli Vaginal Dilator
Manufacturer
Materna Medical
Date Cleared
2023-02-27
(418 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
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Matched: '884.3900'
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
K211959Device Name
Milli Vaginal Dilator
Manufacturer
Materna Medical
Date Cleared
2021-12-01
(160 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
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Matched: '884.3900'
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
K202542Device Name
Allura Vaginal Stent
Manufacturer
PMT Corporation
Date Cleared
2020-09-30
(28 days)
Product Code
KXP
Regulation Number
884.3900Why did this record match?
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Matched: '884.3900'
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
K130273Device Name
PANPAC VAGINAL DILATORS
Manufacturer
Panpac Medical Corporation
Date Cleared
2013-08-08
(185 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
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Matched: '884.3900'
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
K071754Device 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
884.3900Why did this record match?
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Matched: '884.3900'
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
K063562Device Name
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
Manufacturer
ETHICON, INC.
Date Cleared
2007-02-26
(91 days)
Product Code
OTP
Regulation Number
884.5980Why did this record match?
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Matched: '884.3900'
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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