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510(k) Data Aggregation

    K Number
    K240434
    Device Name
    RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
    Manufacturer
    Li Medical Corporation Ltd.
    Date Cleared
    2024-09-25

    (224 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
    Device Description
    The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).
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    K Number
    K201952
    Device Name
    CrossGlide ETS Plus
    Manufacturer
    CrossBay Medical
    Date Cleared
    2020-08-05

    (22 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CrossGlide™ ETS Plus is indicated for use for sonohysterography and to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.
    Device Description
    The CrossGlide™ ETS Plus is a sterile, disposable, single-use device which enables saline infusion sonohysteroraphy and the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS Plus contains a Delivery Catheter with an everting Membrane, an Inner Aspiration Catheter that contains a lumen for saline infusion and aspiration. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. A proximal luer connector allows a 10cc luer lock syringe to infuse saline into the uterine cavity for sonohysterography. The 10cc syringe can be used to remove the saline from the uterine cavity and create negative pressure. Movement of the CrossGlide™ ETS Plus device, after creating negative pressure with the 10cc syringe, removes material and tissue from the uterine cavity.
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    K Number
    K192534
    Device Name
    CrossBay Endometrial Tissue Sampler (ETS)
    Manufacturer
    CrossBay Medical
    Date Cleared
    2020-03-25

    (191 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.
    Device Description
    The CrossGlide™ ETS, Endometrial Tissue Sampler, is a sterile, disposable, single-use device which enables the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS contains a Delivery Catheter with an everting Membrane and an Inner Aspiration Catheter. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. Movement of the ETS device, after creating negative pressure with the 3cc syringe, removes material and tissue from the uterine cavity.
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    K Number
    K102847
    Device Name
    DISPOSABLE ENDOMETRIAL SUCTION CURETTE
    Manufacturer
    JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
    Date Cleared
    2011-04-14

    (197 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: Endometrial cancer detection, Determine response to estrogen replacement therapy, Detection of pathology resulting in: Infertility, menstrual disorders, abnormal or dysfunctional uterine bleeding, postmenopausal bleeding, endometrial dating.
    Device Description
    The proposed device is single-use, sterile disposable endometrial suction curette, which is intended to obtain endometrial tissue samples by vacuum suction mainly for endometrial histopathology examination and cytological examination or clinical examination in Gynaecological examination. Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.
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    K Number
    K092982
    Device Name
    THE PANPAC SUCTION CURETTE
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2010-07-26

    (301 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
    Device Description
    An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction.
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    K Number
    K051294
    Device Name
    FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
    Manufacturer
    FEMSPEC L.L.C.
    Date Cleared
    2005-12-21

    (217 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It is indicated for: - Cancer screening - Endometrial dating - Determining response to estrogen replacement therapy - Bacterial culturing - Detection of pathology resulting in infertility - Monitoring patients receiving Tamoxifen therapy - Evaluating secondary amenorrhea
    Device Description
    FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.
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    K Number
    K040189
    Device Name
    ENDOMETRIAL SAMPLING SYRINGE
    Manufacturer
    ROCKET MEDICAL PLC
    Date Cleared
    2004-10-04

    (250 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following: - For histological biopsy of the endometrium & endo-cervix in post menopausal screening. . - Hormone therapy monitoring. . - Endometrial dating . - Detection of endometrial carcinoma . - Bacterial culturing .
    Device Description
    This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.
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    K Number
    K030935
    Device Name
    BERKELEY V-10 VACUUM CURETTAGE SYSTEM
    Manufacturer
    ACMI CORPORATION
    Date Cleared
    2003-06-23

    (90 days)

    Product Code
    HHI
    Regulation Number
    884.5070
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For rapid transcervical aspiration of the uterine cavity.
    Device Description
    The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested.
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    K Number
    K021876
    Device Name
    MAS WITH OR WITHOUT SYRINGE
    Manufacturer
    MARINA MEDICAL INSTRUMENTS, INC.
    Date Cleared
    2003-04-08

    (305 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE DEVICE IS INDICATED FR USE To Rt MATERIAL THE UTERUS 1010 UTERUS By SCRAPING / / N THE AND SUCTION IN ORDER TO OBTAIN નિર રે. 151-624 LOGICAL MENSTRALAL of for EXTRACTIO
    Device Description
    The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only. The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.
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    K Number
    K020628
    Device Name
    CURELLE, PREFERRED CURELLE, CUTEQ 2.5
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Date Cleared
    2002-05-24

    (87 days)

    Product Code
    HHK
    Regulation Number
    884.1175
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.
    Device Description
    An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5
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