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510(k) Data Aggregation

    K Number
    K240713
    Device Name
    TRAUMAGEL®
    Manufacturer
    Cresilon, Inc.
    Date Cleared
    2024-08-14

    (152 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
    Device Description
    TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.
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    K Number
    K240097
    Device Name
    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
    Manufacturer
    Ushare Medical Inc.
    Date Cleared
    2024-05-22

    (131 days)

    Product Code
    QSY, OSY
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.
    Device Description
    The Polysaccharide Hemostatic Powder (HP-2, HP-5) are sterile, topical wound dressings comprised of plant base polysaccharides. The hemostatic particles contained in powder absorb the water in the blood through physical adsorption, so that the blood components are concentrated to form a stable clot and achieve the purpose of hemostasis.
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    K Number
    K232216
    Device Name
    Hemoblock_S (Prescription); Hemoblock_S (OTC)
    Manufacturer
    Incore Co., Ltd.
    Date Cleared
    2024-04-19

    (268 days)

    Product Code
    QSY, OSY
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions
    Device Description
    The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following; - Gauze(N) Type: There is not strap yarn part on the Hemoblock_S - Gauze(S) Type: There is strap yarn part on the Hemoblock_S The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.
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    K Number
    K240454
    Device Name
    RESPONDER® Polysaccharide Hemostat
    Manufacturer
    Starch Medical, Inc.
    Date Cleared
    2024-03-15

    (29 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
    Device Description
    RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyroqenic and derived from plant starch. The device contains no human or animal components.
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    K Number
    K220525
    Device Name
    RESPONDER Polysaccharide Hemostat
    Manufacturer
    Starch Medical, Inc.
    Date Cleared
    2023-12-04

    (649 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESPONDER® Polysaccharide Hemostat Rx is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
    Device Description
    RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch. The device contains no human or animal components.
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    K Number
    K230589
    Device Name
    Celox Rapid X-Ray Gauze
    Manufacturer
    Medtrade Products Ltd.
    Date Cleared
    2023-11-17

    (260 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
    Device Description
    Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip. Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.
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    K Number
    K211570
    Device Name
    Zeolite Hemostatic Gauze
    Manufacturer
    Hangzhou Zeo-Innov Life Technology Co., Ltd.
    Date Cleared
    2022-02-10

    (265 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
    Device Description
    The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
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    K Number
    K202830
    Device Name
    Axiostat Patch
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2021-04-15

    (202 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
    Device Description
    The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted. The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation.
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    K Number
    K192671
    Device Name
    Hemostatic Xerogel Sponge
    Manufacturer
    Solaplus Biotech Co., Ltd.
    Date Cleared
    2020-08-28

    (337 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
    Device Description
    The proposed device, Hemostatic xerogel sponge, is available in three models for different size. The Hemostatic Xerogel Sponge is a irradiation sterilized, single used device, and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 2 years.
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    K Number
    K190012
    Device Name
    OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
    Manufacturer
    Medtrade Product Ltd
    Date Cleared
    2019-12-18

    (349 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    QSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French
    Device Description
    OMNI-STAT Vascular Rapid is a chitosan-based hemostatic dressing/ pad presented in a sealed foil pouch, consisting of hemostatic granules with a bioadhesive bonded to one side of non-woven gauze and with a PU foam film backing on the other side of the gauze. The dressing is designed to control surface bleeding from vascular access sites. The granules coated side is applied directly to the access site and pressure applied until hemostasis is achieved. OMNI-STAT Vascular Rapid achieves its principle intended action (hemostasis) by creating a physical barrier or plug to stop the flow of blood. The granules coated sides is applied directly to the access site and the point of compression, while the sheath is still in place. When the sheath is removed, and the product comes into contact with blood, with pressure applied OMNI-STAT Vascular Rapid with the bio-adhesive quickly forms a gel like plug absorbing the water from the blood.
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