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This document contains the 510(k) summary for the Next Gen EMG Endotracheal Tube by Medtronic Xomed, Inc. It outlines the device's purpose, indications for use, description, and comparisons with predicate

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How to fill out Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube

1. Gather all necessary information about the Next Gen EMG Endotracheal Tube, including its intended use, design, and materials.
2. Identify and compile any existing predicates that are similar devices already cleared by the FDA.
3. Complete the 510(k) application form accurately, ensuring all sections are filled out with relevant data.
4. Prepare and include a comprehensive description of the device, including technical specifications and drawings.
5. Conduct performance testing and gather results, including clinical data if applicable, to demonstrate safety and effectiveness.
6. Include labeling and packaging information that complies with FDA regulations.
7. Submit the 510(k) to the FDA along with the payment for the submission fee.
8. Respond promptly to any requests for additional information from the FDA during their review process.

Who needs Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube?

1. Manufacturers of medical devices that require FDA clearance for marketing in the U.S.
2. Healthcare providers looking for innovative and safe medical solutions for patient care.
3. Investors interested in supporting medical device companies that are regulatory compliant.

People Also Ask about

What does FDA 510 K clearance mean?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What is the purpose of 510k?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is a 510 K submission?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the 501k process?

How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

What does 501k clearance mean?

The purpose of a 510(k) submission is to demonstrate that a medical device is similar enough to an FDA-approved device known as a predicate device. This process requires documented evidence to compare the new device with the predicate device. Laboratory testing is necessary, but human testing may not be required.

Who is required to submit a 510 K?

Domestic manufacturers introducing a device to the U.S. market; Finished device manufacturers must submit a 510(k) if they manufacture a device ing to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices.

For pdfFiller’s FAQs

What is Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube?

The Traditional 510(k) Submission for the Next Gen EMG Endotracheal Tube is a regulatory pathway used to demonstrate that a new medical device is substantially equivalent to an existing, legally marketed device. This process typically involves providing data and documentation to the FDA to show that the new device is safe and effective.

Who is required to file Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube?

Manufacturers and importers of medical devices that wish to market the Next Gen EMG Endotracheal Tube in the United States are required to file a Traditional 510(k) Submission if the device is classified as a Class II device and is not exempt from 510(k) requirements.

How to fill out Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube?

To fill out a Traditional 510(k) Submission for the Next Gen EMG Endotracheal Tube, applicants must provide information including device description, indications for use, technological comparison to predicate devices, labeling, and performance data. The submission must follow the format outlined in the FDA's guidelines.

What is the purpose of Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube?

The purpose of the Traditional 510(k) Submission for the Next Gen EMG Endotracheal Tube is to allow manufacturers to demonstrate to the FDA that their device is safe and effective for use, ensuring that it meets regulatory requirements for marketing in the U.S.

What information must be reported on Traditional 510(k) Submission, Next Gen EMG Endotracheal Tube?

The information that must be reported in a Traditional 510(k) Submission for the Next Gen EMG Endotracheal Tube includes device identification, manufacturer information, intended use, technological characteristics, comparisons to predicate devices, test results for safety and effectiveness, and proposed labeling.