Get the free K 122656 510 (K) SUMMARY MAY 0 62014 This summary of 5 10(K) safety and effectivenes...

K 122656 510 (K) SUMMARY MAY 0 62014 This summary of 5 10(K) safety and effectiveness information is being submitted in accordance with requirements of SODA 1990 and 21CFR 807.92. 1. Submitter's Identification:

How to fill out k 122656 510 k

How to fill out k 122656 510 k:

1. Start by gathering all the necessary information and documents required to complete the form. This may include details about the medical device, its intended use, testing data, and any previous submissions made for the device.
2. Carefully review the instructions and guidelines provided by the FDA for filling out the k 122656 510 k form. Familiarize yourself with the sections and questions included in the form to ensure accurate and complete information submission.
3. Begin filling out the form by providing all the requested general information. This can include the name and contact details of the applicant, device manufacturer information, and the device's generic and proprietary names.
4. Proceed to complete the sections related to device identification. Provide accurate details about the device, its model, and any applicable codes or standards it adheres to.
5. In the next sections, provide a comprehensive description of the device's intended use, technological characteristics, and the specific indications for use. Include information about the patient population, the device's mode of action, and any design features that make it unique.
6. If applicable, include any information related to the device's performance testing. This may involve providing test results, protocols, and comparisons to predicate devices to demonstrate the device's safety and effectiveness.
7. Additionally, include any information about the device's labeling, including instructions for use, warnings, and precautions. It is crucial to ensure that the labeling complies with relevant regulatory requirements.
8. Review the completed form for accuracy and ensure that all required sections have been addressed. Double-check the provided information for any errors or omissions that may hinder the review process.

Who needs k 122656 510 k:

1. Manufacturers of medical devices that have made significant modifications to an existing device and seek clearance from the FDA to market the modified device generally require the k 122656 510 k form. This form is used to demonstrate the safety and effectiveness of the modified device compared to its predicate device.
2. Companies or individuals seeking to introduce a new medical device that is not substantially equivalent to a previously cleared device may also need the k 122656 510 k form. This form helps in obtaining FDA clearance for marketing the device by demonstrating its safety and effectiveness.
3. It is important to note that the specific requirements for obtaining clearance through a k 122656 510 k submission may vary depending on the type and classification of the medical device. Always consult the FDA's guidelines and regulations or seek professional assistance to ensure compliance with the necessary requirements.

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What is k 122656 510 k?

k 122656 510 k is a form filed with the Food and Drug Administration (FDA) for medical device premarket notification.

Who is required to file k 122656 510 k?

Manufacturers who intend to market a medical device in the United States are required to file k 122656 510 k.

How to fill out k 122656 510 k?

To fill out k 122656 510 k, manufacturers must provide detailed information about the medical device, including its intended use, design, materials, and performance data.

What is the purpose of k 122656 510 k?

The purpose of k 122656 510 k is to demonstrate to the FDA that a medical device is safe and effective for its intended use.

What information must be reported on k 122656 510 k?

Information reported on k 122656 510 k includes device description, intended use, design verification and validation data, and labeling.