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510(k) Data Aggregation

    K Number
    K130087
    Device Name
    PANPAC WORD/BARTHOLIN CATHETER
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2014-01-10

    (361 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panpac Word/ Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.
    Device Description
    Not Found
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    K Number
    K102141
    Device Name
    COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2011-05-06

    (281 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for the treatment of abscesses and cysts of the Bartholin gland.
    Device Description
    The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use.
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    K Number
    K093904
    Device Name
    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
    Manufacturer
    GLENVEIGH SURGICAL, LLC
    Date Cleared
    2010-04-14

    (113 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
    Device Description
    The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.
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    K Number
    K082939
    Device Name
    COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2009-09-03

    (336 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.
    Device Description
    The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage procedure in order to prolong pregnancy to a successful delivery. The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cervical cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The Cook® Fetal Membrane Manipulator is comprised of a November polycarbonate dual lumen catheter with a silicone balloon. The balloon catheter assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.
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    K Number
    K062438
    Device Name
    BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
    Manufacturer
    COOK OB/GYN
    Date Cleared
    2006-10-27

    (67 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
    Device Description
    The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.
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    K Number
    K060289
    Device Name
    EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
    Manufacturer
    FRONTLINE MEDICAL
    Date Cleared
    2006-07-07

    (151 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure. V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.
    Device Description
    EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use. V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.
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    K Number
    K013597
    Device Name
    TAMPONADE UTERINE BALLOON CATHETER SET
    Manufacturer
    COOK OB/GYN
    Date Cleared
    2002-04-17

    (168 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile. "Use of this device is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted."
    Device Description
    The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum uterine bleeding. The materials of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.
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    K Number
    K014248
    Device Name
    DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
    Manufacturer
    UROGYN LTD.
    Date Cleared
    2002-03-21

    (85 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of Pelvic organ prolapse/vaginal prolapse and is equivalent to the currently employed procedure, which is performed with the Deschamps™ device, distributed by BEI Medical Systems Corporation. The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.
    Device Description
    The UroGyn DND 202™ device is a surgical tool, consisting of a plastic thimble connected to an operating box. The thimble element of the device contains a surgical needle and a cartridge preloaded with suture material. The DND 202™ is mounted on the surgeon's index finger and controlled externally. DND 202™ allows the surgeon to operate guided by palpation only. The device is used to anchor the suture material to dense connective tissue at the hipbone during Bladder Neck Suspension for the treatment of Urinary Incontinence or Pelvic Organ Prolapse. The vaginal mucosa is open through surgical incision and the surgeon's finger, with the thimble of the DND 202 mounted on it, is placed through the incision to palpate the desired anatomical structure. The device is then operated externally by the other hand causing the projection of the surgical needle into the tissue. The needle reaches the opposite side of the device and retrieves the suture material from the cartridge. A reverse motion of the needle with the suture material hooked at the tip of the needle retracts the needle back into its housing. The surgeon remove his hand with the device out of the vagina, release the suture material from the needle and ends up with two ends of the suture material anchored to the target connective tissue and ready for tying.
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    K Number
    K001590
    Device Name
    DND 101
    Manufacturer
    UROGYN LTD.
    Date Cleared
    2000-08-02

    (77 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990738
    Device Name
    DR. JAHANGER'S CUTTER
    Manufacturer
    M.S. JAHANGER, MD
    Date Cleared
    1999-10-29

    (238 days)

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

    KNA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.
    Device Description
    Not Found
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