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510(k) Data Aggregation

    K Number
    K240523
    Device Name
    VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
    Manufacturer
    Shenzhen VitaVitro Biotech Co., Ltd.
    Date Cleared
    2024-11-15

    (266 days)

    Product Code
    MQE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures. VitaVitro Double Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
    Device Description
    The Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. This product is a disposable, sterile medical device, sterilized by ethylene oxide.
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    K Number
    K232163
    Device Name
    Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
    Manufacturer
    Zhejiang Horizon Medical Technology Co., Ltd.
    Date Cleared
    2024-02-22

    (216 days)

    Product Code
    MQE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures. Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
    Device Description
    The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles. The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length. The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.
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    K Number
    K223689
    Device Name
    Disposable Needle Guides and Grids
    Manufacturer
    Advance Medical Designs, Inc.
    Date Cleared
    2023-08-02

    (236 days)

    Product Code
    ITX
    Regulation Number
    892.1570
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
    Device Description
    Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
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    K Number
    K222052
    Device Name
    VitroPRO
    Manufacturer
    CIVCO Medical Instruments Co., Inc.
    Date Cleared
    2022-11-22

    (133 days)

    Product Code
    ITX, MOE
    Regulation Number
    892.1570
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers. - Transvaginal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy fluid aspiration, catheter placement, treatment, and oocyte retrieval. - Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.
    Device Description
    The disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.
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    K Number
    K190590
    Device Name
    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
    Manufacturer
    Allwin Medical Devices, Inc.
    Date Cleared
    2019-11-25

    (263 days)

    Product Code
    MQE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allwin Ovum Pickup Needles are used for laparoscopic or ultrasound guided transvaginal retrieval of oocytes from ovarian follicles.
    Device Description
    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle).
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    K Number
    K191291
    Device Name
    Wallace Dual Lumen Oocyte Recovery System
    Manufacturer
    CooperSurgical, Inc.
    Date Cleared
    2019-06-12

    (29 days)

    Product Code
    MQE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
    Device Description
    The Wallace Dual Lumen Oocyte Recovery System consists of a 33 cm dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System is available in 16 or 17-gauge color-coded sizes (16G-Blue and 17G-Red). The needles are available in three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.
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    K Number
    K182959
    Device Name
    Wallace Dual Lumen Oocyte Recovery System
    Manufacturer
    CooperSurgical Inc.
    Date Cleared
    2019-05-10

    (197 days)

    Product Code
    MQE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
    Device Description
    The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source. The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.
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    K Number
    K171625
    Device Name
    Single Lumen Ovum Aspiration Needles
    Manufacturer
    Willian A. Cook Australia Pty Ltd
    Date Cleared
    2018-01-12

    (224 days)

    Product Code
    MQE, MOE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
    Device Description
    Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.
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    K Number
    K171611
    Device Name
    Double Lumen Ovum Aspiration Needles
    Manufacturer
    William A. Cook Australia Pty Ltd
    Date Cleared
    2017-12-15

    (197 days)

    Product Code
    MQE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Double Lumen Ovum Aspiration Need for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
    Device Description
    Double Lumen Ovum Pick-up Needles consist of a double lumen stainless steel needle with a manipulating handle. The manipulating handle has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via a secondary lumen. The needle is intended to be used to aspirate oocytes from follicles of human ovaries via a laparoscopic or ultrasound guided transvaginal path. The Double Lumen Ovum Aspiration Needles are sterile and single-use devices. The Double Lumen Ovum Aspiration Needles are available in 16 or 17 gauge sizes and three lengths: 30, 33 and 35 cm. The needles are provided with an aspiration tube of 75 cm length and a vacuum tube with a length of 70 or 100 cm.
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    K Number
    K172050
    Device Name
    Follicle Aspiration Set, Reduced Single Lumen
    Manufacturer
    Vitrolife Sweden AB
    Date Cleared
    2017-11-21

    (138 days)

    Product Code
    MQE, MOE
    Regulation Number
    884.6100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for flushing and/or aspiration of oocytes from ovarian follicles.
    Device Description
    The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components: - A stainless steel needle . - A silicone cork to be pushed into the opening of a sampling tube . - A length of TPE-O tubing for aspiration and flushing ● - An adapter for flushing . The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.
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