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510(k) Data Aggregation

    K Number
    K231023
    Device Name
    ERBEJET® 2 System
    Manufacturer
    Erbe Elektromedizin GmbH
    Date Cleared
    2023-06-15

    (65 days)

    Product Code
    FQH, GEI
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use - Hydrosurgical unit: The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures. Indications for Use - Applicators and ERBEJET probe: 20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used free injection including lifting of mucosal lesions by injection into the submucosa. 20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. 20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa. 20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2. 20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.
    Device Description
    The ERBEJET® 2 System includes the Hydrosurgical unit model ERBEJET® 2, the pump cartridge plus, instruments (applicators and ERBEJET probe), an optional suction model ESM 2 with accessories and a one- or two-pedal footswitch. Together these components form the ERBEJET® 2 System. The system provides an adjustable high-pressure water jet (pressurized normal saline solution) intended for tissue-selective hydrodissection and needle-free injection in endoscopic and/or surgical interventions. The ERBEJET® 2 unit together with its accessories is an active invasive surgical system. The sterile normal saline solution is the "medium" which is projected under pressure through a nozzle of the connected instrument to achieve the desired tissue effect.
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    K Number
    K220759
    Device Name
    Armis VeriCyn Wound Wash
    Manufacturer
    Armis Biopharma, Inc.
    Date Cleared
    2023-05-25

    (436 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).
    Device Description
    The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, including microorganisms from wounds though the use of a lavage system. ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA and Purified water. VeriCyn® Wound Wash has been tested for compliance with ISO 10993.
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    K Number
    K220964
    Device Name
    VERSAJET Hydrosurgery System (III)
    Manufacturer
    Smith & Nephew Medical Limited
    Date Cleared
    2023-05-16

    (410 days)

    Product Code
    FQH
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement: - wound debridement (acute and chronic wounds, burns), - soft tissue debridement and cleansing of surgical sites.
    Device Description
    The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces. The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister. The pressure can be adjusted using either the foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.
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    K Number
    K221504
    Device Name
    BD Surgiphor™ Antimicrobial Irrigation System
    Manufacturer
    BD
    Date Cleared
    2022-10-14

    (144 days)

    Product Code
    FQH
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.
    Device Description
    The subject BD Surgiphor™ Antimicrobial Irrigation System is a terminally sterilized 450 mL aqueous solution for irrigation and debridement of wounds. The device includes one bottle of Surgiphor™ solution (0.5% Povidone Iodine) which is used to loosen and remove wound debris. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the loosening and removal of debris, and foreign materials, including microorganisms, from wounds. The povidone iodine in the Surgiphor™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.
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    K Number
    K222804
    Device Name
    Irrisept Antimicrobial Wound Lavage
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2022-09-22

    (6 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
    Device Description
    Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K210987
    Device Name
    IRRIGO Wound Wash Jet System
    Manufacturer
    Inopro Inc
    Date Cleared
    2022-05-31

    (425 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns.
    Device Description
    IRRIGO Wound Wash Jet System is a sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water for Irrigation and packaged in a food grade compressible translucent LDPE 2oz (60mL) bottle with a LPDE luer-lock type tip spray insert and an HPDE colored cap.
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    K Number
    K213616
    Device Name
    BD Surgiphor Antimicrobial Irrigation System
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2022-03-23

    (128 days)

    Product Code
    FQH, FOH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.
    Device Description
    The BD Surgiphor™ Antimicrobial Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of Surgiphor™ Solution (0.5% Povidone Iodine) which is used first to loosen wound debris, and one bottle of SurgiRinse™ Solution (saline solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, and foreign materials, including microorganisms, from wounds. The BD Surgiphor™ Antimicrobial Irrigation System is provided as a two-part terminally sterilized system with 450 mL of each solution. The povidone in the Surgiphor™ Solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.
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    K Number
    K210536
    Device Name
    Irrisept Antimicrobial Wound Lavage
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2021-05-28

    (93 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
    Device Description
    Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K202222
    Device Name
    Irrisept Wound Debridement and Cleansing System
    Manufacturer
    Irrimax Corporation
    Date Cleared
    2020-12-14

    (130 days)

    Product Code
    FQH, FOH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
    Device Description
    Irrisept® Wound Debridement and Cleansing System is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
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    K Number
    K202071
    Device Name
    SURGIPHOR Wound Irrigation System
    Manufacturer
    Orthophor, LLC
    Date Cleared
    2020-10-23

    (88 days)

    Product Code
    FQH, FOH
    Regulation Number
    880.5475
    Why did this record match?
    Product Code :

    FQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
    Device Description
    SURGIPHOR™ Wound Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of SURGIPHOR™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. The povidone iodine in the SURGIPHOR™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.
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