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510(k) Data Aggregation

    K Number
    K163556
    Device Name
    MediClear PreOp
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2017-09-14

    (269 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    COVALON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp can be left on the preoperative incision site for up to 7 days. MediClear™ PreOp is intended to be used on intact skin and for external use only.
    Device Description
    MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination. MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance. MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.
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    K Number
    K150550
    Device Name
    SilverCoat Silicone Foley Catheter
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2015-11-24

    (266 days)

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

    COVALON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used as a urological catheter inserted through the urinary tract by individuals that are > 30 kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.
    Device Description
    SilverCoat™ Silicone Foley Catheters are 100% silicone Foley catheters that have a lubricious coating impregnated with silver ions. The silver is retained in the hydrophilic coating through ionic bonding and is covalently bonded to the silicone surface. The coating will not peel, flake or crack. The coating hydrates rapidly becoming slippery (lubricious) and maintains its lubricity for at least seven days. The SilverCoat™ catheter complies with the FDA recognized consensus standard, ASTM F623-99 Standard Performance Specification for Foley Catheter. The catheters are comprised of a twolumen shaft with proximal funnel, inflation valve, and distal retaining balloon. Balloon fill volumes are in millimeters and the shaft size is in French (Fr.) which is indicated on the funnel of each individual catheters are supplied in individually packaged, sealed single use pouches and they are sterilized by ethylene oxide. The SilverCoat™ Foley Catheter is a prescription-only device and it is intended to be used in healthcare facility/hospital, home, and ambulatory settings.
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    K Number
    K121819
    Device Name
    SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2012-08-13

    (53 days)

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

    COVALON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiClear™ is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires. SurgiClear™ may also be used to cover and secure primary dressing. SurgiClear™ inhibits microbial growth within the dressing and prevents external contamination.
    Device Description
    SurgiClear™ is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.
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    K Number
    K112549
    Device Name
    IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2012-05-04

    (246 days)

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

    COVALON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.
    Device Description
    IV Clear® is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.
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    K Number
    K043296
    Device Name
    COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2005-06-06

    (189 days)

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

    COVALON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including: Pressure ulcers, Diabetic ulcers, Ulcers caused by mixed vascular etiologies, Venous ulcers, First and Second degree burns, Donor and graft sites, Abrasions, Dehisced surgical wounds, Traumatic wounds healing by secondary intention.
    Device Description
    ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is an advanced wound care dressing composed of collagen, sodium alginate and silver chloride provided in a sterile sheet or rope form. ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds.
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    K Number
    K050177
    Device Name
    COLACTIVE COLLAGEN WOUND DRESSING
    Manufacturer
    COVALON TECHNOLOGIES, INC.
    Date Cleared
    2005-04-27

    (91 days)

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

    COVALON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ColActive™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including: - Pressure ulcers - Diabetic ulcers - Ulcers caused by mixed vascular etiologies - Venous ulcers - Second degree burns - Donor and graft sites - Abrasions - Dehisced surgical wounds - Traumatic wounds healing by secondary intention
    Device Description
    ColActive™ Collagen Wound Dressing is an advanced wound care dressing composed of collagen and sodium alginate provided in a sterile sheet or rope form. Collagen Wound Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds.
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