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510(k) Data Aggregation

    K Number
    K242002
    Device Name
    FemVue MINI Saline-Air Device
    Manufacturer
    Femasys Inc.
    Date Cleared
    2024-11-22

    (136 days)

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

    Femasys Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
    Device Description
    Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.
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    K Number
    K241693
    Device Name
    FemChec Controlled Saline-Air Device (FCD-250)
    Manufacturer
    Femasys Inc.
    Date Cleared
    2024-09-06

    (86 days)

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

    Femasys Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
    Device Description
    FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.
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    K Number
    K231730
    Device Name
    FemaSeed Intratubal Insemination
    Manufacturer
    Femasys Inc.
    Date Cleared
    2023-09-22

    (101 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Femasys Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance
    Device Description
    The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health. Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance. Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.
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    K Number
    K122658
    Device Name
    FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2012-12-20

    (111 days)

    Product Code
    PCF
    Regulation Number
    884.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMASYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: further evaluation of an abnormal Pap smear; cervical lesions extending into the endocervical canal; undiagnosed uterine bleeding.
    Device Description
    The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation.
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    K Number
    K110993
    Device Name
    FEMCHEC PRESSURE MANAGEMET DEVICE
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2011-10-12

    (187 days)

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

    FEMASYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg. The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.
    Device Description
    The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.
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    K Number
    K110288
    Device Name
    FEMVUE SALINE-AIR DEVICE
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2011-04-28

    (86 days)

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

    FEMASYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemVue™ Saline-Air Device instills a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
    Device Description
    The FemVue™ Saline-Air Device is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter to instill saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity.
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    K Number
    K100662
    Device Name
    FEMVUE CORNUAL BALLOON CATHETER
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2010-04-07

    (30 days)

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

    FEMASYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemVue™ Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
    Device Description
    The FemVue Cornual Balloon Catheter ("FCBC") is a latex-free Balloon Catheter within a transcervical Delivery Sheath.
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    K Number
    K083690
    Device Name
    FEMVUE(TM) CATHETER SYSTEM
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2009-06-23

    (193 days)

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

    FEMASYS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemVue™ Catheter System is intended for the delivery of contrast media during hysterosalpingography (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
    Device Description
    The FemVue Catheter System ("FCS") is comprised of two components: a Sheath and a latex free balloon Catheter. The Sheath is used to deliver the Catheter into the uterus.
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