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510(k) Data Aggregation

    K Number
    K233524
    Device Name
    Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2024-05-03

    (184 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & Sleeved IC 2 Plus Pocket (16" and 8"): This 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. Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.
    Device Description
    The Sleeved IC 2 (not finalized) catheters are: - E-beam sterilized. - Hydrophilic-coated, single use catheter. - Have two drainage eyelets that is used to manage urinary incontinence. - The Sleeved IC is inserted into the urethra to drain urine from the bladder. - Available in 16 inch and 8 inch lengths. - Available in various Fr sizes ranging from Fr 08 through Fr 16. - Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC. - Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter. - Lubricated by direct contact with the hydration fluid. - Available with and without integrated urine collection bag. - Available in pocket and straight packaging configurations. - Environment of use: hospital, home setting, public places.
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    K Number
    K220667
    Device Name
    Sleeved IC
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2022-12-08

    (276 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 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 Sleeved IC (final name to be determined) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Sleeved IC is inserted into the urethra to drain urine from the bladder. The catheter is available in 16in length. The catheter is available in 12 and 14 Fr sizes. The catheter is provided in a sterile manner, utilization method. The device is made from Thermo-plastic Elastomer (TPE) and is phthalate free and PVC free. This directly hydrated catheter is packaged in a foil pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid.
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    K Number
    K213575
    Device Name
    Female IC (Not Finalized)
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2022-09-13

    (307 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This intermittent catheter is a flexible tubular device that is inserted through the urethra by female pediatic patients who need to drain urine from the bladder.
    Device Description
    The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.
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    K Number
    K211436
    Device Name
    Intermittent Catheter (Not Finalized)
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2022-01-27

    (262 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 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 Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.
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    K Number
    K193148
    Device Name
    VaPro Plus Pocket, VaPro Plus
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2019-12-13

    (30 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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
    This submission is to add an additional size (Fr 08) to the currently cleared 16-inch Pocket and Plus Pocket configurations of VaPro 2. The VaPro 2 Pocket Line Extension is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Pocket Line Extension has the following features: - Hydrophilic-coated PVC catheter (phthalate free) - Two smooth catheter eyelets - Protective sleeve - Protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion - Color-coded funnel. - Urine Collection bag (for the Plus Pocket version) The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store. In the Plus Pocket configuration, the urinary catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
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    K Number
    K191633
    Device Name
    Infyna Chic
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2019-07-19

    (30 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This intermittent catheter is a flexible tubular device that is inserted through the urethra by female patients who need to drain urine from the bladder.
    Device Description
    The Infyna Chic is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. Infyna Chic has the following features: - Hydrophilic-coated PVC catheter (phthalate free) - Two smooth catheter eyelets - Color-coded funnel The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The primary packaging is designed to be easy to open, close and dispose of, with a discrete consumer design. The outer packaging also contains a 'first use label' that indicates to the end user if the product was previously opened.
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    K Number
    K183253
    Device Name
    ValPro 2 Plus, VaPro 2 Plus Pocket
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2018-12-18

    (27 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 2 Plus and VaPro 2 Plus Pocket is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Plus and VaPro 2 Plus Pocket has the following features: - Hydrophilic-coated PVC catheter (phthalate free) - Two smooth catheter eyelets - Protective sleeve - Protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion - Color-coded funnel - Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style) - Urine Collection bag The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
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    K Number
    K180824
    Device Name
    VaPro 2 Intermittent Catheter
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2018-06-22

    (84 days)

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

    Hollister Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 2 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. VaPro 2 has the following features: - Hydrophilic-coated PVC catheter (phthalate free) - Two smooth catheter eyelets - Protective sleeve - Protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion - Color-coded funnel - Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style) The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging, (Standard and Pocket), was designed to facilitate access for those with limited dexterity. The Pocket version was designed to be discreet and easy to store.
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    K Number
    K163179
    Device Name
    Onli Intermittent Catheter
    Manufacturer
    HOLLISTER INCORPORATED
    Date Cleared
    2017-01-26

    (73 days)

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

    HOLLISTER INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 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 Onli intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements: Σ Ready to use, single use intermittent catheter Σ Hydrophilic-coated, phthalate free catheter Σ Two smooth catheter eyelets Σ Color coded funnel Σ Not made with natural rubber latex Σ Gripper on the16-in. catheter to aid with insertion The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be easy to open and facilitate access to the catheter.
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    K Number
    K152268
    Device Name
    VAPRO PLUS POCKET Intermittent Catheter
    Manufacturer
    HOLLISTER INCORPORATED
    Date Cleared
    2015-09-09

    (29 days)

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

    HOLLISTER INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VaPro Plus Pocket 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 Plus Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements: - hydrophilic-coated PVC catheter (phthalate free) - Two smooth catheter eyelets - protective sleeve - protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion - color coded funnel The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
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