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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.

The provided document for K130782, the AccuMesh Positioning System, does not contain information related to acceptance criteria or a study proving device performance. This 510(k) submission is solely for adding an orange ink component to an already cleared device.

Therefore, I cannot extract the requested information using the provided text.

Here's why:

• Nature of the Submission: This is a 510(k) summary for a minor change (component color addition) to an existing, cleared device. Such submissions typically focus on demonstrating that the change does not alter the fundamental safety or effectiveness of the device, rather than presenting new performance studies or acceptance criteria.
• Missing Sections: The document lacks sections typically found in an initial 510(k) submission that would detail performance data, clinical studies, or engineering tests against specific acceptance criteria.
• Focus on Equivalence: The primary goal of this particular 510(k) is to establish substantial equivalence to previously cleared AccuMesh devices, emphasizing that "There are no changes to the technological characteristics as a result of the proposed colorant addition."

If you have a document for an initial clearance of the AccuMesh Positioning System (e.g., K101218, K103269, or K123066), that document might contain the information you're looking for.

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