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510(k) Data Aggregation

    K Number
    K151710
    Device Name
    SNaP Wound Care System
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2015-11-19

    (148 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SNaP System with SNaP Cartridge (60cc): The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts. SNaP System with SNaP Plus Cartridge (150cc): The SNaP® Wound Care System is indicated for patients who would management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.
    Device Description
    The SNaP® Wound Care System ("SNaP System") is a non-powered, portable, singleuse, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is based on the concept of forced expansion of volume to produce negative pressure at the wound bed or at the closed incision, utilizing dedicated constantforce springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. It is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician.
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    K Number
    K142272
    Device Name
    SNaP Wound Care System
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2014-11-25

    (102 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.
    Device Description
    The SNaP® Wound Care System ("SNaP System") is a non-powered, portable, single-use, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management via application of negative pressure to the wound or closed incision for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System is able to generate negative pressure to allow for the removal of wound exudate/fluid from a wound bed or from a closed incision, utilizing dedicated constant-force springs that mechanically generate the negative pressure gradient. The SNaP System has no electrically powered parts and is disposable after use. This 510(k) premarket notification is for design modifications to the 60cc SNaP Cartridge component of the predicate SNaP Wound Care System, in order to introduce a larger capacity 150cc cartridge available with 125mmHg pressure setting.
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    K Number
    K132080
    Device Name
    SNAP WOUND CARE SYSTEM
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2014-03-12

    (250 days)

    Product Code
    OKO, NEG
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.
    Device Description
    The SNaP® Wound Care System ("SNaP System") is an existing (K081406, K111393, K112341, K 113032) non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The proposed SNaP Wound Care System will have the same indication for use as the predicate device, the SNaP Wound Care System (K113032). In addition, Spiracur has added the SNaP® Bridge Dressing Kit ("SNaP Bridge Dressing") and SNaP® SecurRing" Hydrocolloid ("SNaP SecurRing") to the SNaP Dressing Kit product family.
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    K Number
    K133137
    Device Name
    CISNAP CLOSED INCISION SYSTEM
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2014-02-25

    (137 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ciSNaP® Closed Incision System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.
    Device Description
    The ciSNaP® Closed Incision System ("ciSNaP System") is a new addition to Spiracur Inc.'s ("Spiracur") family of negative pressure wound management devices. The ciSNaP System is a portable, non-powered, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management through the removal of small amounts of exudate from surgically closed incisions. The ciSNaP System utilizes the concept of forced expansion of volume to produce negative pressure at the closed incision. The ciSNaP System can be applied in the sterile field. The ciSNaP System has no electrically powered parts and is disposable after use. Additionally, it is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician. The dressing component of the ciSNaP System incorporates an antimicrobial interface.
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    K Number
    K113032
    Device Name
    SNAP WOUND CARE SYSTEM
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2011-12-01

    (50 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious naterial and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.
    Device Description
    The SNaP® Wound Care System ("SNaP System") is a portable, non-powered suction device intended for wound management via application of negative pressure to the wound bed for removal of fluids, including wound exudate, irrigation fluids and infectious materials.
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    K Number
    K112341
    Device Name
    SNAP WOUND CARE SYSTEM
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2011-08-29

    (14 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SNaP® Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
    Device Description
    The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.
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    K Number
    K111393
    Device Name
    SNAP (R) WOUND CARE SYSTEM
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2011-07-28

    (71 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SNaP Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts.
    Device Description
    The SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The SNaP Wound Care System is designed to provide active wound treatment through the removal of excess exudates, infectious material and tissue debris. The SNaP Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), surgically closed incisions, flaps and grafts. The SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The SNaP Wound Care System is used in conjunction with the SNaP Dressing Kit.
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    K Number
    K111006
    Device Name
    CI-SNAP WOUND CARE SYSTEM
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2011-07-21

    (101 days)

    Product Code
    OKO, QKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CI-SNaP™ Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.
    Device Description
    The CI-SNaP Wound Care System is a non-powered, portable, single-use suction device intended for wound management via application of negative pressure to the wound for removal of fluids, including exudate, irrigation fluids and infectious materials. The CI-SNaP Wound Care System is designed to provide active wound treatment to help promote healing in surgical incisions that continue to drain following sutured or stapled closure. The CI-SNaP Wound Care System utilizes dedicated constant-force springs to mechanically generate the negative pressure gradient. The CI-SNaP™ Wound Care System is used in conjunction with the CI-SNaP™ Dressing Kit.
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    K Number
    DEN080011
    Device Name
    SNAP WOUND CARE DEVICE
    Manufacturer
    SPIRACUR, INC.
    Date Cleared
    2009-08-07

    (277 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIRACUR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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