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510(k) Data Aggregation

    K Number
    K223866
    Device Name
    Carevix™ Suction Cervical Stabilizer
    Manufacturer
    Aspivix SA
    Date Cleared
    2023-01-25

    (33 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.
    Device Description
    Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.
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    K Number
    K203820
    Device Name
    ASPIVIX v1.1 Cervical Suction Tenaculum
    Manufacturer
    Aspivix S.A.
    Date Cleared
    2021-08-17

    (231 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
    Device Description
    ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.
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    K Number
    K142204
    Device Name
    Bioceptive Suction Cervical Retractor
    Manufacturer
    Bioceptive Inc.
    Date Cleared
    2014-12-19

    (130 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bioceptive Suction Cervical Retractor is indicated to snare, grasp, hold and manipulate cervical tissue.
    Device Description
    Not Found
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    K Number
    K082349
    Device Name
    JARIT HULKA UTERINE TENACULUM FORCEPS
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS, INC.
    Date Cleared
    2008-11-21

    (98 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.
    Device Description
    JARIT Hulka Uterine Tenaculum Forceps are an 11-inch long stainless steel, ring-handled instrument with ratchet closure having a single-tooth hook at the distal end of one arm and a 3.6 mm diameter uterine sound probe at the distal end of the other arm. The device is reusable, sterilizable and packaged non-sterile.
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    K Number
    K073182
    Device Name
    GYN DISPOSABLES TENACULUM 356T
    Manufacturer
    GYN-DISPOSABLES, INC.
    Date Cleared
    2007-11-28

    (15 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Snare, grasp, hold and manipulate cervical and intravaginal tissue.
    Device Description
    GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
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    K Number
    K062563
    Device Name
    FEMTEN CERVICAL TENACULUM
    Manufacturer
    FEM SUITE, L.L.C.
    Date Cleared
    2007-05-18

    (260 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemSuite, LLC, FemTen™ Cervical Tenaculum is a sterile, disposable, manual instrument indicated for single patient use to hold and manipulate the cervix. This device is typically used in conjunction with endometrial biopsy.
    Device Description
    Not Found
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    K Number
    K060573
    Device Name
    BURBANK TENACULUM
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2006-04-21

    (46 days)

    Product Code
    HDC, DXC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures. This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
    Device Description
    The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place. A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.
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    K Number
    K032585
    Device Name
    TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
    Manufacturer
    RON-TECH MEDICAL LTD.
    Date Cleared
    2004-01-09

    (141 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
    Device Description
    The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to hold and secure the ultrasound transducer in place on a uterine tenaculum, while performing the sonographic procedure. The configuration of the device allows the physician to manipulate the ultrasound transducer with one hand, thus freeing the other hand to perform the required procedure. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System consists of a reusable uterine tenaculum with an adaptor bar, a sterile, disposable adaptor and a disposable probe connector.
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    K Number
    K030078
    Device Name
    BURBANK TENACULUM, MODEL 09-0011-01
    Manufacturer
    VASCULAR CONTROL SYSTEMS, INC
    Date Cleared
    2003-01-24

    (15 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.
    Device Description
    The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.
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    K Number
    K001818
    Device Name
    UTERINE TENACLUM HOOK
    Manufacturer
    TOWNE BROTHERS (PVT.), LTD.
    Date Cleared
    2000-08-30

    (76 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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