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For Prescription Use: MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control moderate to severe bleeding.

For OTC (Over The Counter) Use: MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.

The MedTrade Products CELOX Hemostatic Granules on Sheet is nearly identical to the legally marketed MedTrade Products CELOX Hemostatic Granules (K061079, cleared April 20, 2006) in product design composition and processing in that the same CELOX Hemostatic Granules are mechanically heat bonded on to a viscose sheet. The Sheet provides a controlled and accurate delivery System to ensure that the CELOX Hemostatic Granules are applied directly onto the wound site as quickly and efficiently as possible. On contact with blood CELOX Hemostatic Granules that are heat bonded on to the surface of the viscose sheet cause hemostasis.

This is a 510(k) premarket notification for the Medtrade Products CELOX Hemostatic Granules on Sheet. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the format requested.

The document is a letter from the FDA to Medtrade Products Ltd. confirming the substantial equivalence of their device to legally marketed predicate devices. It outlines the regulatory classification, product codes, and general controls provisions of the Act. It also specifies the Indications for Use for both prescription and over-the-counter use of the device.

To address your request, specifically point 1-9, the document does not provide the details required, as it is a regulatory clearance letter and not a detailed study report. It states that the device is "nearly identical" to a previously cleared device (K061079) and that "the indications for use are similar to the HemCon ChitoFlex Surgical (K071519) and Scion Cardio-Vascular Clo-Sur Plus PAD (K032986)." This implies that the substantial equivalence was based on similarity to previously cleared devices rather than new performance studies detailed in this document.

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