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510(k) Data Aggregation

    K Number
    K150350
    Device Name
    Flexi-Seal Signal Fecal Management System
    Manufacturer
    ConvaTec Ltd.
    Date Cleared
    2015-07-21

    (160 days)

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

    ConvaTec Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.
    Device Description
    The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer-lock syringe, a collection bag with cap and a cinch clamp to pinch off flow in the catheter when required for medication retention or to stop waste flow. The components are contained in a rigid thermoformed plastic clamshell. The catheter main drain tube is fabricated from collapsible silicone rubber with the addition of an odor adsorber, which is added in order to help contain the fecal odor which often permeates through the wall of the catheter. The drain tube has a low-pressure silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and also available separately) at the proximal end. There is a recess (pocket) under the balloon for the clinician's finger, which allows the device to be positioned digitally. Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication if prescribed. An additional sampling port is located on the side of the catheter, which allows access to clinicians for stool sample collection. A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal. The device, collection bag and syringe are intended for single us, are provided non-sterile and contain no components made with animal products, natural rubber latex or DEHP.
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    K Number
    K140953
    Device Name
    GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
    Manufacturer
    CONVATEC LTD.
    Date Cleared
    2014-08-01

    (109 days)

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

    CONVATEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
    Device Description
    The intermittent urinary catheter is a thin hollow tube, fitted with a connector at one end and an olive tip (ball) at the other, which is inserted intermittently through the urethra and up to the bladder so that urine can drain. Both components are prepared from plastic materials and are bonded by cyclohexanone. The products are designed for transient use only and are available in various diameters; six FR (CH) sizes: FR08, FR10, FR12, FR14, FR16 and FR18. An increasing French size corresponds to a larger external diameter. The catheter is primary packaged in a paper/film peelpack and is sterilized by Ethylene Oxide. The catheter tube has a smooth, clear surface with two lateral eyelets and closed angled tip with small ball called an olive. Eyelets are placed on the left and right site of the catheter and the angled portion of the catheter tip is oriented upward.
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    K Number
    K973688
    Device Name
    DUODERM CONTROL GEL FORMULA BORDER DRESSING
    Manufacturer
    CONVATEC LTD.
    Date Cleared
    1997-12-23

    (88 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONVATEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue,
    Device Description
    The concept of DuoDERM CGF Control Gel Formula Border Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.
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    K Number
    K973689
    Device Name
    DUODERM HYDROACTIVE DRESSING
    Manufacturer
    CONVATEC LTD.
    Date Cleared
    1997-12-23

    (88 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONVATEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.
    Device Description
    The concept of DuoDERM Hydroactive Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.
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