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The EVICELTM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL™ fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO2 pressure utilizing the pressure regulator unit) onto the surface.

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This document is an FDA 510(k) clearance letter for the EVICEL™ Application Device, classifying it as a Class II piston syringe. It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory clearance and substantial equivalence to a predicate device.

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The EVICEL TM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL TM fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO 2 pressure utilizing the pressure regulator unit) onto the surface.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. The letter confirms that the device, EVICEL™ Application Device, has been found substantially equivalent to a legally marketed predicate device based on its intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided document.

Ask a specific question about this device