Get the free 510(k) Summary or 510(k) Statement

This document provides a summary of the 510(k) premarket notification for the Disposable Laryngeal Electrodes manufactured by Technomed Europe. It outlines details such as the manufacturer\'s information, device description, intended use, and the comparison to predicate devices. The electrodes are designed for non-invasive monitoring of laryngeal nerves during surgeries, improving safety and minimizing infection risks.

How to fill out 510k summary or 510k

How to fill out 510k summary or 510k

1. Identify the device classification and determine if it requires a 510(k).
2. Compile a comprehensive description of the device, including its intended use and technological characteristics.
3. Identify the predicate device(s) and demonstrate substantial equivalence.
4. Prepare detailed labeling information including instructions for use.
5. Conduct performance testing, including bench, animal, or clinical studies if applicable.
6. Compile all necessary documentation and complete the 510(k) application form.
7. Pay the required user fee to the FDA.
8. Submit the 510(k) electronically via the FDA's eSubmission gateway.

Who needs 510k summary or 510k?

1. Manufacturers who wish to market a medical device that is not exempt from premarket notification.
2. Companies looking to make modifications to existing devices that may affect safety or efficacy.
3. Any entity intending to introduce a device that relies on claims of substantial equivalence to an already marketed device.

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What is 510k summary or 510k?

A 510(k) summary is a document submitted to the FDA that demonstrates that a medical device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file 510k summary or 510k?

Manufacturers of medical devices intending to market their products in the U.S. are required to file a 510(k) summary if their device is not exempt from premarket notification.

How to fill out 510k summary or 510k?

The 510(k) form must be completed by providing information about the device, its intended use, and data supporting substantial equivalence to a predicate device. Guidance from the FDA should be followed for specific requirements.

What is the purpose of 510k summary or 510k?

The purpose of the 510(k) process is to ensure that a new medical device is safe and effective, ultimately allowing it to be marketed in the U.S.

What information must be reported on 510k summary or 510k?

The 510(k) must include device description, intended use, labeling, summary of technological characteristics, performance data, and substantial equivalence comparison to a predicate device.