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A summary report detailing the safety and effectiveness of the Cstat vascular clamp device submitted for FDA clearance under 510(k) regulations, including technical specifications and compliance with

How to fill out 510k k032125 - amendment

How to fill out 510(k) K032125 - Amendment 1

1. Gather necessary information about the device, including its intended use, description, and any predicate devices.
2. Complete the 510(k) form, ensuring all sections are filled out accurately, including administrative data and device description.
3. Perform a risk analysis to identify potential hazards associated with the device.
4. Prepare performance data and results from relevant tests to demonstrate the device's safety and effectiveness.
5. Include labeling information that complies with FDA requirements.
6. Submit any necessary fees associated with the filing of the 510(k).
7. Review the completed submission for accuracy before sending it to the FDA.
8. Respond promptly to any requests for additional information from the FDA during their review process.

Who needs 510(k) K032125 - Amendment 1?

1. Manufacturers of medical devices that wish to market a new device that is substantially equivalent to an already marketed device.
2. Companies seeking to make modifications to an existing medical device that affect its safety or effectiveness.
3. Developers of medical devices that require a premarket notification before they can be legally marketed in the United States.

People Also Ask about

What is an FDA 510K number?

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

What is a 501k submission to the FDA?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What does 510 k exempt mean?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510K and FDA approval?

On the path to market, a granted de novo request has roughly the same weight as a “cleared” 510(k) submission. Both mean that FDA has opened the door to the market. FDA Approved: This term is reserved for the highest risk “Pre market approval” or PMA devices.

What does 510 K clearance mean?

It's important to note that clearance under the 510(k) pathway does not indicate that the FDA has approved the device but rather that the FDA has determined the device is equivalent to a similar device already on the market.

What is the FDA granted 510 K clearance?

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).

Is 510 K the same as FDA approval?

A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act).

For pdfFiller’s FAQs

What is 510(k) K032125 - Amendment 1?

510(k) K032125 - Amendment 1 is a regulatory submission to the FDA that provides information about a medical device, showing that it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) K032125 - Amendment 1?

Manufacturers of medical devices that wish to market their products in the U.S. and have made changes to the originally submitted 510(k) or are introducing a new device that is claimed to be substantially equivalent to an existing device are required to file this amendment.

How to fill out 510(k) K032125 - Amendment 1?

To fill out 510(k) K032125 - Amendment 1, one must complete the FDA's 510(k) form, provide required documentation including device description, intended use, predicate device information, as well as any changes made, and submit it electronically to the FDA.

What is the purpose of 510(k) K032125 - Amendment 1?

The purpose of 510(k) K032125 - Amendment 1 is to update or provide additional information regarding a medical device to demonstrate continued compliance with regulatory requirements and ensure safety and effectiveness.

What information must be reported on 510(k) K032125 - Amendment 1?

The information that must be reported includes device identification, modifications made, summary of safety and effectiveness, labeling, and any relevant studies or data that support the claims of substantial equivalence.