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510(k) Data Aggregation

    K Number
    K123804
    Device Name
    INSTAFLO BOWEL CATHETER SYSTEM KIT
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2013-04-17

    (128 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
    Device Description
    The InstaFio Bowel Catheter System Kit contains two main parts: the catheter (made with odor barrier film) and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.
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    K Number
    K100273
    Device Name
    INSTAFLO BOWEL CATHETER SYSTEM KIT
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2010-04-22

    (83 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
    Device Description
    The InstaFlo Bowel Catheter System Kit contains two main parts: the catheter and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.
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    K Number
    K090960
    Device Name
    VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2009-08-20

    (136 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VaPro intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
    Device Description
    The VaPro intermittent catheter is a hydrophilic coated single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.
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    K Number
    K083153
    Device Name
    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2009-02-04

    (103 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.
    Device Description
    The ActiFlo Indwelling Bowel Catheter System consists of a rectal catheter and accessories (waste collection bag, irrigation bag, skin barriers, syringe and lubricating jelly). The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.
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    K Number
    K050483
    Device Name
    EVADRI BLADDER CONTROL SYSTEMS
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2005-04-12

    (47 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.
    Device Description
    The evadri Bladder Control System is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in an office, clinic, or hospital. The evadri office prisitials, maros marse entronyography or pressure biofeedback from pelvic musculature. The device also provides electrical stimulation to the pelvic musculature. The modalities of biofeedback and electrical stimulation are intended for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of incontinence.
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    K Number
    K040779
    Device Name
    RESTORE WOUND CLEANSER
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2004-05-17

    (52 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
    Device Description
    The Restore Wound Cleanser is a buffered isotonic water based surfactant solution that is a clear colorless slightly viscous liquid that is intended to remove foreign material such as dirt is a debris from dermal wounds. The device can be used on low, medium or high exudating and wounds. The product is available in an 80z. spray bottle. The Restore Wound Cleanser is applied to the dermal wound area using a trigger spray closure that helps facilitate the removal of foreign material such as dirt and debris.
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    K Number
    K013612
    Device Name
    INCARE PELVIC FLOOR THERAPY SYSTEM
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2002-03-19

    (134 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence. The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
    Device Description
    The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence. The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.
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    K Number
    K013653
    Device Name
    INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2002-03-05

    (119 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
    Device Description
    The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.
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    K Number
    K013483
    Device Name
    INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2002-01-14

    (87 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
    Device Description
    The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy insertion and user convenience. The catheter gel is contained in an integral reservoir, which eliminates gel migration throughout the package. The InCare Advance and Advance Plus catheters are sterile, non-latex, polyvinyl chloride catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. Both catheters incorporate a no-touch design, which enables the user to easily insert the catheter without direct hand contact, thus reducing the possibility of contamination. The InCare Advance Plus Intermittent Catheter has an introducer tip that is intended to reduce reoccurring UTI and a collection bag to contain urine. The InCare Advance Plus is also available in a kit known as InCare Advance Plus Kit. The InCare Advance and Advance Plus pre-lubricated intermittent catheters are available in various sizes and with a straight or coude tip to accommodate a wide range of male, female, and pediatric end users.
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    K Number
    K013345
    Device Name
    INCARE INTERMITTENT CATHETER
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    2002-01-07

    (90 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOLLISTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
    Device Description
    The InCare Intermittent Catheters are intended to be used as a means of managing urinary incontinence by draining urine from the bladder. The InCare Intermittent Catheters are sterile, non-latex, PVC catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. The InCare Intermittent catheters are available in various sizes to accommodate a wide range of male, female, and pediatric end users.
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