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This document outlines the 510(k) summary for Embrace Thermoplastic, detailing the device's classification, intended use, substantial equivalence to existing products, and summary of testing and compliance

How to fill out 510k summary for embrace

How to fill out 510(k) Summary for Embrace Thermoplastic

1. Gather relevant product information and specifications for the Embrace Thermoplastic.
2. Identify the intended use and indications for use of the device.
3. Compile a list of technological characteristics and compare them with a legally marketed device.
4. Conduct and include performance testing results, if applicable.
5. Document any potential safety risks associated with the Embrace Thermoplastic.
6. Prepare a summary of the substantial equivalence to the predicate device.
7. Review the 510(k) guidelines and ensure all required sections are complete.
8. Submit the 510(k) Summary to the FDA through the appropriate channels.

Who needs 510(k) Summary for Embrace Thermoplastic?

1. Manufacturers of medical devices that intend to market the Embrace Thermoplastic in the U.S.
2. Developers needing FDA clearance for the Embrace Thermoplastic.
3. Companies looking to prove substantial equivalence to an existing product.

People Also Ask about

What are the three types of 510k?

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).

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the difference between FDA 510k and CE?

CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards. A 510(k) is a premarket submission made to the FDA.

What is the 510k FDA 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 the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What does 501k clearance mean?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

For pdfFiller’s FAQs

What is 510(k) Summary for Embrace Thermoplastic?

The 510(k) Summary for Embrace Thermoplastic is a document submitted to the FDA that demonstrates that the Embrace Thermoplastic device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for Embrace Thermoplastic?

Manufacturers of the Embrace Thermoplastic device who wish to obtain clearance for marketing in the U.S. must file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary for Embrace Thermoplastic?

To fill out the 510(k) Summary, the manufacturer must provide detailed information about the device's design, materials, intended use, performance data, and proposed labeling, along with comparisons to predicate devices.

What is the purpose of 510(k) Summary for Embrace Thermoplastic?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to establish that the Embrace Thermoplastic is safe for its intended use and that it is substantially equivalent to existing devices.

What information must be reported on 510(k) Summary for Embrace Thermoplastic?

The 510(k) Summary must report device identification, intended use, technological characteristics, summary of non-clinical and clinical studies, and proposed labeling information.