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This document serves as a premarket notification submitted to the FDA for the PK ZIP WING Cutting Dissector, a Class II medical device used for electrosurgical cutting and coagulation during surgical

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How to fill out PK ZIP WING Cutting Dissector Premarket Notification

1. Gather all necessary documents and information related to the PK ZIP WING Cutting Dissector.
2. Access the FDA's eSubmission system or the official website to locate the Premarket Notification (510(k)) form.
3. Begin filling out the form by providing the device's name, model number, and intended use.
4. Include a description of the PK ZIP WING Cutting Dissector, highlighting its features and functionalities.
5. Provide detailed information on the device's intended patient population and clinical application.
6. Compile all performance testing data, including bench testing, biocompatibility testing, and any other relevant studies.
7. Summarize how the PK ZIP WING Cutting Dissector is substantially equivalent to a predicate device.
8. Review the entire application for completeness and accuracy before submission.
9. Submit the completed Premarket Notification form along with all required documentation electronically.

Who needs PK ZIP WING Cutting Dissector Premarket Notification?

1. Medical device manufacturers planning to market the PK ZIP WING Cutting Dissector in the United States.
2. Regulatory affairs professionals who are responsible for submitting premarket notifications for new devices.
3. Healthcare providers who are involved in the procurement and use of advanced surgical instruments.
4. Investors and stakeholders interested in understanding the regulatory pathway for medical devices.

People Also Ask about

Who owns 510k?

The FDA guidance document defines the “510(k) submit- ter/holder” as the owner of the 510(k). It also states that although a consultant or correspondent may submit the 510(k) on behalf of the 510(k) owner, that consultant or correspondent is not the 510(k) submitter/holder.

What is a premarket approval?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What are the three 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 is the difference between 510k approval and clearance?

The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.

What is the difference between pre market approval and 510k?

FDA PMA (Premarket Approval) It involves extensive clinical trials and laboratory testing and has higher standards than the 510(k) process, requiring more detailed and comprehensive evidence of the device's safety and effectiveness.

Are FDA 510 K submissions public?

The FDA's database of 510(k) premarket notifications is available for public access on the department's official website.

What is the difference between 510k and premarket approval?

FDA PMA (Premarket Approval) It involves extensive clinical trials and laboratory testing and has higher standards than the 510(k) process, requiring more detailed and comprehensive evidence of the device's safety and effectiveness. The FDA has 180 days to review and decide on a PMA application.

What is premarket notification?

Premarket notification is the process through which these new devices claim substantial equivalency to a preexisting device and are automatically classified into the same class as that predicate device.

For pdfFiller’s FAQs

What is PK ZIP WING Cutting Dissector Premarket Notification?

PK ZIP WING Cutting Dissector Premarket Notification is a submission to the FDA that seeks to demonstrate that a medical device is safe and effective for its intended use before it can be marketed in the United States.

Who is required to file PK ZIP WING Cutting Dissector Premarket Notification?

Manufacturers or importers of the PK ZIP WING Cutting Dissector who intend to sell the device in the U.S. are required to file this premarket notification with the FDA.

How to fill out PK ZIP WING Cutting Dissector Premarket Notification?

To fill out the PK ZIP WING Cutting Dissector Premarket Notification, a manufacturer must include detailed information about the device, including its specifications, intended use, design, manufacturing process, labeling, and any preclinical and clinical data supporting safety and effectiveness.

What is the purpose of PK ZIP WING Cutting Dissector Premarket Notification?

The purpose of the PK ZIP WING Cutting Dissector Premarket Notification is to inform the FDA about a new medical device and to provide data that supports its safety and effectiveness before it can be legally marketed.

What information must be reported on PK ZIP WING Cutting Dissector Premarket Notification?

The information that must be reported includes the device name, classification, intended use, manufacturing information, design specifications, performance testing results, and labeling information.