Get the free 510(k) Summary Submission for Kneehab XP, Type 412/421 - accessdata fda

This document summarizes the premarket notification for the Kneehab XP device, detailing its intended use, regulatory compliance, device description, and equivalence to legally marketed devices.

How to fill out 510k summary submission for

How to fill out 510(k) Summary Submission for Kneehab XP, Type 412/421

1. Collect all necessary product information for Kneehab XP, including intended use and technological characteristics.
2. Review the FDA guidelines for 510(k) submissions to ensure compliance.
3. Complete the 510(k) summary form, detailing the device description, indications for use, and any performance testing conducted.
4. Identify and include a list of any predicates, showing substantial equivalence to Kneehab XP.
5. Prepare documentation for safety and effectiveness data supporting the 510(k) submission.
6. Compile all documentation and forms, ensuring accuracy and completeness.
7. Submit the 510(k) summary electronically via the FDA's eCopy system or as directed.

Who needs 510(k) Summary Submission for Kneehab XP, Type 412/421?

1. Manufacturers of the Kneehab XP device that are seeking FDA clearance to market the product in the United States.
2. Companies who have modified the device or its intended use and require an updated 510(k) submission.

People Also Ask about

How long does it take to get a 510 K approval?

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 type of analysis does a 510 K clearance require?

Clinical data analysis is a critical component of 510(k) clinical studies. The analysis of data enables manufacturers to determine the safety and effectiveness of medical devices and to identify any potential risks or adverse events.

What does 510 K clearance mean?

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).

How to view 510 k submissions?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

What is needed for a 510 K submission?

Proper documentation of the device design — Detailed documentation of the device design and how it works is a critical component of the 510(k) submission. The documentation must include drawings, schematics, and a description of the device's intended use and performance.

How to prepare a 510 K submission?

1. Preparing for the submission process Identifying a predicate device. Special controls, guidance, and software considerations. Clinical data inclusion. Pre-Submission (or Q-submission) Demonstrating substantial equivalence. Writing a clear and compelling submission. Interpreting the FDA's feedback.

What is the 5 10k approval process?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

How long does a 510 K submission take?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

For pdfFiller’s FAQs

What is 510(k) Summary Submission for Kneehab XP, Type 412/421?

The 510(k) Summary Submission for Kneehab XP, Type 412/421 is a premarket submission made to the FDA to demonstrate that the device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary Submission for Kneehab XP, Type 412/421?

The manufacturer or legal sponsor of the Kneehab XP device is required to file the 510(k) Summary Submission.

How to fill out 510(k) Summary Submission for Kneehab XP, Type 412/421?

To fill out the 510(k) Summary Submission, manufacturers need to provide basic information about the device, its intended use, detailed descriptions, and performance testing results, along with any labeling and promotional materials.

What is the purpose of 510(k) Summary Submission for Kneehab XP, Type 412/421?

The purpose of the 510(k) Summary Submission is to inform the FDA and the public about the device's safety and effectiveness and to establish that it is substantially equivalent to an existing, legally marketed device.

What information must be reported on 510(k) Summary Submission for Kneehab XP, Type 412/421?

The information that must be reported includes the device's name, intended use, description of the device, identification of predicate devices, performance data, labeling information, and any safety and effectiveness information.