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This document summarizes the safety and effectiveness of the Universal Operating Hysteroscope Set by Solima - Zupi, providing detailed information on the device's intended use, technological characteristics,

How to fill out 120 510k summary of

How to fill out 12.0 510(k) Summary of Safety and Effectiveness

1. Begin by assembling all necessary documentation related to the medical device.
2. Clearly define the device, including its name, model number, and intended use.
3. Provide a description of the technological characteristics of the device, including its design and materials.
4. Identify and describe any predicate devices you are referencing.
5. Present a summary of non-clinical and clinical studies that demonstrate safety and effectiveness.
6. Include any potential risks associated with the device and how they are mitigated.
7. Detail manufacturing information, including quality control measures.
8. Complete the summary with any additional information requested by the FDA.

Who needs 12.0 510(k) Summary of Safety and Effectiveness?

1. Manufacturers seeking to market a medical device that is substantially equivalent to a predicate device.
2. Companies that need FDA clearance for their device under the 510(k) process.
3. Importers and distributors involved in the marketing of medical devices.

People Also Ask about

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is 501k approval?

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 510k summary?

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 510k clearance process?

The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US, as data from the FDA shows that: 35% of medical devices are in Class I, the lowest risk class, as they present minimal potential for harm to the end user.

What is the 501k process?

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 510k summary report?

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 FDA granted 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.

For pdfFiller’s FAQs

What is 12.0 510(k) Summary of Safety and Effectiveness?

The 12.0 510(k) Summary of Safety and Effectiveness is a document required by the FDA that provides evidence demonstrating that a medical device is safe and effective for its intended use. It is submitted for devices that are similar to those already legally marketed in the U.S.

Who is required to file 12.0 510(k) Summary of Safety and Effectiveness?

Manufacturers of medical devices that are intending to market a device that is substantially equivalent to one that is already legally marketed in the U.S. must file the 12.0 510(k) Summary of Safety and Effectiveness with the FDA.

How to fill out 12.0 510(k) Summary of Safety and Effectiveness?

To fill out a 12.0 510(k) Summary, the manufacturer must provide information about the device, including its intended use, technological characteristics, comparison to predicate devices, clinical data (if applicable), and labeling. The form must be completed accurately and submitted electronically to the FDA.

What is the purpose of 12.0 510(k) Summary of Safety and Effectiveness?

The purpose of the 12.0 510(k) Summary is to demonstrate to the FDA that the new device is as safe and effective as, or substantially equivalent to, an existing legally marketed device, thus allowing it to be cleared for marketing.

What information must be reported on 12.0 510(k) Summary of Safety and Effectiveness?

The 12.0 510(k) Summary must include device identity, description, intended use, predicate device comparison, summary of safety and effectiveness data, proposed labeling, and any other pertinent information that shows substantial equivalence.